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  • Dispositivo 4
  • Fabricante 4
  • Evento 124969
  • Implante 0
Alerta De Seguridad para Test Xpert® MRSA/SA BC
  • Tipo de evento
    Safety alert
  • ID del evento
    RRD-021116
  • Número del evento
    INVIMA 2008RD-0001050
  • Fecha
    2016-11-08
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=115
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The sanitary agency notifies, that the manufacturer cepheid, informs that the test kits xpert® mrsa / sa bc., with.
Alerta De Seguridad para Xpert EV (enterovirus) Assay
  • Tipo de evento
    Safety alert
  • ID del evento
    RRD-100316
  • Número del evento
    INVIMA 2008RD-0001050
  • Fecha
    2016-03-16
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=151
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    Reports from clients that have presented a greater number of results generated by the analyzer are called "detection of signal loss" (loss of detection signal, e5011). therefore, patient results are not generated when using this test.
Notificaciones De Seguridad De Campo acerca de Euphora Quick Change Balloon Dilation Catheters
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2017/728 & FA779
  • Fecha
    2017-07-17
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20171208225323/http://www.titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2017-728-SGB.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Arctic Gel Pad
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/279 & FA2016-10
  • Fecha
    2016-03-23
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170817063516/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016_279_sgb.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de SONNET Mini Battery Slot Cable
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/1003 & 16-002
  • Fecha
    2016-10-31
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170817123506/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016-1003-sgb.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Perceval Sutureless Heart Valve
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/770 & FSCA_HV 2016-002
  • Fecha
    2016-08-15
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170815224606/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016-770-SGB.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Skintact ECG Electrode DF31L
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/162 & CAP-06-0062
  • Fecha
    2016-02-23
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170817153003/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016-162-SGB.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Ethicon Physiomesh Flexible Composite Mesh
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/486 & Ethıcon physıomesh- Gönüllü Ürün Geri Toplaması
  • Fecha
    2016-05-26
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170818091739/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016-486%20SGB.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de iChem Velocity Automated Urine Chemistry System
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/91 & FSCA-15048
  • Fecha
    2016-01-28
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170817131519/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016-91%20SGB.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Endoscopic Suction Tube
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/741 & 2955842-07/14/16-010-R
  • Fecha
    2016-08-09
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170817085305/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016_741_sgb.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de IBC Aortic Punch
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2015/1212 & CAPA15-07
  • Fecha
    2015-12-24
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170817053158/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2015-1212%20SGB.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de HemoCue HbA1c 501
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/207 & P-H-150311-01
  • Fecha
    2016-03-08
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170817113011/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016-207%20SGB.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de MobiCath Bi-Directional Guiding Sheath
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2017/235 & 2183787-02/07/2017-001-r
  • Fecha
    2017-02-21
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20171014004732/http://www.titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2017-235%20sgb.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de METS Modular Tumour System
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/1133 & SO-2016-626
  • Fecha
    2016-12-13
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170613070734/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016-1133%20sgb.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Endo Peanut Automatic Suture Blunt Dissector 5mm
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2017/668 & FA771
  • Fecha
    2017-05-23
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20171208225308/http://www.titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2017-668-SGB.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Emprint Percutaneous Antenna Thermosphere Tech
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/201 & V26989
  • Fecha
    2016-03-04
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170817112619/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016_201_sgb.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Cordis Precise Pro RX Nitinol Stent System
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/438 & Cordis20160504_OUS
  • Fecha
    2016-05-09
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170818070553/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016-438-SGB.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Smart Flex Vascular Stent System
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2017/234 & Cordis20170216
  • Fecha
    2017-02-22
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20171014002608/http://www.titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2017-234%20sgb.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Check-Flo® Hemostasis Unit, Flexor® Radial Access ...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2017/193 & 2017FA0002
  • Fecha
    2017-02-15
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20171014014923/http://www.titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/sgb-2017-193.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Codman Microcoil Delivery System and Separation Co...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2017/236 & 1226348-10-25-16-001R
  • Fecha
    2017-02-20
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20171013233452/http://www.titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2017-236%20sgb.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Lotus Valve System
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/771 & 91131010AC-FA
  • Fecha
    2016-08-11
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170815211705/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016-771-SGB.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Vascular Guide Catheter, single-use
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/891 & RA2016-124
  • Fecha
    2016-10-10
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170817142123/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016-891%20SGB.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Sports Medicine and Trauma Products
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/361 & HHE 15-20
  • Fecha
    2016-04-22
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170817041706/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016-361%20SGB.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de ACDA-A (Anticoagulant Citrate Dextrose Solution)
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/804 & HHE CL 15-001
  • Fecha
    2016-08-03
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170817101933/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016-804%20SGB.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de M. HINTON 2 SHEEP BLOOD 90 20PL
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2016/427 & FSCA 2893
  • Fecha
    2016-05-09
  • País del evento
    Turkey
  • Fuente del evento
    TDMDAT
  • URL de la fuente del evento
    https://web.archive.org/web/20170818072009/http://titck.gov.tr/PortalAdmin/Uploads/Titck/Dynamic/2016-427%20SGB.pdf
  • Notas / Alertas
    Turkish data is current through July 2017. All of the data comes from Turkey’s Drugs and Medical Devices Agency (Titck), 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 Turkey.
  • Notas adicionales en la data
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Aviso

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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