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  • Dispositivo 26
  • Fabricante 14
  • Evento 124969
  • Implante 0
Notificaciones De Seguridad De Campo acerca de Cryptococcal Antigen Lateral Flow Assay
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-01-04
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    The affected lots’ negative predictive value remains unchanged and is nearly 100%. it is only the positive predictive value that is affected. thus, you may choose to continue to use the affected lots to report negative results and perform alternative confirmatory testing on all positive specimens. however, there are risks associated with this choice. the crag lfa is the most sensitive, commercially-available test for cryptococcal antigen. the risk associated with confirming all positive specimens with a less sensitive test is that true, low titer specimens may be negative using a less sensitive test method. thus, a true, low titer positive specimen may be incorrectly reported as negative. clinical evidence must be used in conjunction with test results. .
Notificaciones De Seguridad De Campo acerca de 2M Inlay 15 ° for MUTARS® RS Cup and LUMiC® TiN
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-12-28
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    While training users with sterile packaged original parts, it was found that at 2m inlay 15 ° for the mutars® rs cup and lumic® tin ø 38/39 mm, one safety ring was incorrectly mounted in the inlay groove. it cannot be ruled out that this installation error may have occurred in other sizes.
Notificaciones De Seguridad De Campo acerca de bellavista ventilators
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2016-03-17
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Imtmedical has identified a potential risk associated with the user interface controller software of the bellavista ventilator. please ensure that all potential users are made aware of this safety notification and the recommended actions.
Notificaciones De Seguridad De Campo acerca de Offset Reamer Handle
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    On june 14, 2016 greatbatch medical identified an issue with the 00-7804-080-00 offset reamer handle, as field complaints were reported that the drive chain mechanism seizes during use. the function of the drive chain mechanism is to transmit rotational power from a mechanical drill to an acetabular reamer during a total hip arthroplasty. during seizing, the device is rendered non- functional in the operating room. the risks associated with this failure are: 1. the offset reamer handle seizes and the surgery must be completed with an alternate device, leading to a delay of 30 minutes or greater from the scheduled surgery time. 2. the offset reamer handle seizes and no replacement device is available in the hospital, leading to an interruption and rescheduling of surgery. .
Notificaciones De Seguridad De Campo acerca de Camino® Advanced Monitor
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2013-12-09
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Lntegra lifesciences corporation (lntegra) has identified that there is a possibility that some customers received a camino® advanced monitor (camol), in which the optional sys/dias mode displays reversed systolic and diastolic intracranial pressure (icp) values. the camino® advanced monitor is a compact. portable device displaying intracranial pressure, intracranial temperature (ict), and calculating cerebral perfusion pressure (cpp).
Notificaciones De Seguridad De Campo acerca de CADstream
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Choosing the wrong network or using an unsupported network can lead to incorrect biopsy results or failure to address the objective of the investigation.
Notificaciones De Seguridad De Campo acerca de eFilm Workstation
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    This issue happens for rf projection images. if user measures on rf image, "cal" (calibration) is not displayed and measurement is not correct.
Notificaciones De Seguridad De Campo acerca de BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-06-05
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    There is a possibility the valve of the bvm manual resuscitation system may become stuck during storage. this could result in the intended tidal volume not being delivered through the valve, which may cause a delay in treatment. the instructions for use provided with these products include the requirement to ensure the bag, valve and oxygen delivery is functioning correctly prior to use. this field safety notice gives additional information relating to this specific problem and the additional actions required. .
Notificaciones De Seguridad De Campo acerca de BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-12-22
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    A manufacturing fault has been identified with the intersurgical bvm manual resuscitation system, which could result in the directional valves positioned on the ‘back plate’ of the self- inflating bag being orientated incorrectly. the images show the incorrect and correct orientation of the directional valves. the incorrect orientation of the directional valves could result in the bvm manual system becoming over pressurised, which could result in patient barotrauma.
Notificaciones De Seguridad De Campo acerca de da Vinci® Standard ™, S ™ and Si ™
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2015-11-13
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    You do not need to return any covers that may have problems with tear-off labels, as stated in past notices. containers that may have problems with tear-off labels can continue to be used if the covers are inspected according to the instructions given in past messages. .
Notificaciones De Seguridad De Campo acerca de Zenostar MT Color and Zenostar MT Color Impulse
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    The primary packaging of these products may show leaks in individual cases. as a consequence, liquid may escape. direct contact with certain substances contained in this liquid may lead to skin irritation. .
Notificaciones De Seguridad De Campo acerca de Barrier Set
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-05-03
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Molnlycke identified a potential safety hazard. during the handling of product complaints, micro perforations on some barrier sets were detected when immersed in the product testing. although the kits are manufactured in the same environment and subsequently sterilized, the sterility of packaged products cannot be guaranteed in this case. molnlycke has taken the risk in this case seriously and is now recalling all the products listed in the attached list.
Notificaciones De Seguridad De Campo acerca de BARRIER® EasyWarm®
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2015-11-04
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Mölnlycke health care barrier® easywarm® product contains warmers to provide heat. according to a stability study the warmers have passed its intended performance for all time points except for 3,5 years, were the product did nog give sufficient amount of heat. based on this mölnlycke health care gives an advisory notice that products that are 2 years old or older should be scrapped and will be replaced free of charge by mölnlycke health care.
Notificaciones De Seguridad De Campo acerca de Permobil C300, C350, C400, and C500
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-07-26
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Permobil ab has voluntarily initiated remedial action for certain models of permobil motorized wheelchairs with fixed seats and lifting inner tubes. the decision for this remedial action was made because of a possible failure of the upper panel, where the seat system is separated from the base. the top panel is the component that connects the wheelchair seat system to the base with several welds.
Notificaciones De Seguridad De Campo acerca de VESA 75 / 100 adaptation with rotation
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    We have within the framework of our ongoing quality checks unfortunately ascertained that in the case of the article "vesa 75 / 100 adaptation with rotation", which is part of our monitor mounts and support arms, the riveting of the rotation may possibly not have been carried out according to the specifications. in exceptional cases, it can lead to a loosening thereof, respectively to a loosening of the connection plate in the case of continuous use, which can in turn lead to a risk to patients, users or third parties. for this reason we have decided to carry out a replacement action. on account of the fact that no case of damage has hitherto occurred in practice, this relates to preventive measure with regard to our deliveries, for the limited time period from may to november 2015. based on our records, we have discerned that you have been supplied by us, with the affected products, during the aforementioned time period. a detailed list of relevant orders can be found in an annex to this letter. .
Notificaciones De Seguridad De Campo acerca de Panocell®-20
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-02-20
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Immucor is issuing this product notification regarding the v antigen typing for donor e1011, cell #11 of panocell-20, lot 52872. additional dna testing of donor e1011 has confirmed the donor as v–, instead of v+ as indicated on the master list. .
Notificaciones De Seguridad De Campo acerca de Capture-R® Ready-ID®
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-02-20
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Immucor is issuing this product notification regarding the v antigen typing for donor d1741, cell #4 on capture-r ready-id, lots id324 and id325. further dna testing of donor d1741 has confirmed the donor as v–, instead of v+ as indicated on the master list. .
Notificaciones De Seguridad De Campo acerca de LIFECODES Quik-ID Class II (CZID)
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2016-01-08
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    We have determined that the lifecodes quik-ld class ii lot indicated above may generate invalid assays due to high negative serum control (nc) values. per the lifecodes quik-id class ii instructions for use (ifu), the average negative control value must be <_0.225 od. an increase of the nc average od above this limit would result in a failed assay. where the nc is increased without achieving values above this limit, samples may demonstrate false negative results (borderline reactivity) at or near the cutoff for the assay.
Notificaciones De Seguridad De Campo acerca de Kleihauer kit fixing reagent and elution reagent
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2016-12-09
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    The reports are of inconsistent staining of cells and false positives reactivity with negative control samples. the reports indicate the stain is not sufficiently removed from the adult cells during the elution step; therefore it is difficult to distinguish fetal cells from the adult cells. a false positive reaction with the negative control invalidates the test results and a repeat of the test is needed. such repeat of testing may lead to delay in analysis of patient results and ultimately delay in patient treatment. .
Notificaciones De Seguridad De Campo acerca de PANOCELL-20
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    This communication is to inform you of reports that immucor has received concerning unexpected positive reactivity when testing donor n3512 with anti-v. our initial investigation into these reports has confirmed that donor n3512 is v+ when tested with additional sources of anti-v. donor n3512 will be labeled as v+ going forward. .
Notificaciones De Seguridad De Campo acerca de LIFECODES HLA SSO Typing Kits
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-07-07
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    As a result of a complaint investigation, we have concluded the hla-drb1 sso typing kit, the hla-drb1 eres sso typing kit and the hla-dqa1 /b1 sso typing kit have a minor impact due to an error in the match it! dna 3.27.0 allele database update. the iot specific software files for the hla-drb1 sso typing kit (628923), the hla-drb1 eres sso typing kit (628925) and the hla-dqa1/b1 sso typing kit (628930/628930r) have incorrect probe assignments for some alleles which could iead to a potential mistype of certain alleles. .
Notificaciones De Seguridad De Campo acerca de Helioseal Clear
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    We would like to inform you that ivoclar vivadent ag is removing helioseal clear from circulation as a precautionary measure. it cannot be warranted that the material of the affected lot can be sufficiently cured with all polymerization lights. .
Notificaciones De Seguridad De Campo acerca de 4all 1000g
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    The product has been interchanged with another dental alloy with comparable chemical composition. the product you've received is mislabeled.
Notificaciones De Seguridad De Campo acerca de Various devices
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    The affected polisher may suffer increased wear during use. in this case there is no increased health risk to patients, users or the environment.
Notificaciones De Seguridad De Campo acerca de Jarvik 2000 Ventricular Assist System, Adult VAD, ...
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-07-21
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    Jarvik heart, inc. has been requested by the french competent authority, ansm, to issue a field safety corrective action (fsca) based on two (2) incidents involving disconnection of the pedestal cable (jhi-201) resulting from the use of oily or fatty substances near the pedestal connector. both of these disconnections occurred in a hospital environment, activated an alarm. and were promptly addressed by a clinician re-connecting the cable with no harm to the patient. the cable was later replaced. jarvik heart, inc. is aware of only two (2) reportable incidents of this type in over five hundred (500) implants of the post-auricular cable, jhi-001. based on the reported events, the occurrence rate for this type of incident is 0.4%. .
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Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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La International Medical Devices Database está bajo la licencia Open Database License y sus contenidos bajo la licencia Creative Commons Attribution-ShareAlike . Al usar esta data, siempre citar al International Consortium of Investigative Journalists. Puede descargar acá una copia de la base de datos.

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