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  • Dispositivo 3
  • Fabricante 3
  • Evento 124969
  • Implante 0
Notificaciones De Seguridad De Campo acerca de Edi catheter
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2014-11836
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2014/Engangsprodukter--Edi-kateter--Maquet-Critical-Care-AB/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    MCC_14_001_SAL
  • Acción
    Modification of the manual.
Notificaciones De Seguridad De Campo acerca de EDS 3 CSF External drainage system
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2014-74596
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2014/Engangsprodukter--EDS-3-CSF-Externt-draneringssystem--Codman-Neurosciences-SARL/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    1226348-9/10/14-001R
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de Edwards Commander insertion system
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2016-40516
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2016/Engangsprodukter--Edwards-Commander-inforingssystem--Edwards-Lifesciences-LLC1/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FCA-76
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de Edwards Commander insertion system
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2016-40516
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2016/Engangsprodukter--Edwards-Commander-inforingssystem--Edwards-Lifesciences-LLC/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FCA-76
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de Edwards Commander insertion system
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-12274
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2015/Engangsprodukter--Edwards-Commander-inforingssystem--Edwards-Lifesciences-LLC/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FCA-53
  • Acción
    Information on the risk of use.
Notificaciones De Seguridad De Campo acerca de Edwards Commander insertion system
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-12274
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2015/Engangsprodukter--Edwards-Commander-inforingssystem--Edwards-Lifesciences-LLC1/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FCA-53
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de eFilm Workstation/eFilm Lite
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2016-93869
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN20161/Diagnostiska-och-behandlande-stralningsprodukter--eFilm-WorkstationeFilm-Lite--Merge-Healthcare-Incorporated/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    2016-074
  • Acción
    Information on the risk of use. Modification of the software. Temporary measures.
Notificaciones De Seguridad De Campo acerca de EGFR Mutation Analysis Kit
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2016-51513
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2016/In-vitro-diagnostiska-produkter--EGFR-Mutation-Analysis-Kit--EntroGen-Inc/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    EG391946
  • Acción
    Products should be taken out of service. Temporary measures.
Notificaciones De Seguridad De Campo acerca de Octo Nova
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/10043
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2012/Dialyssystem--Octo-Nova--Nikkiso-Europe/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FCA-NE-06
  • Acción
    Instructions on use of the products. Reminder of important information. Control of products. Modification of products.
Notificaciones De Seguridad De Campo acerca de Octo Nova
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/51308
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2012/Dialyssystem--Octo-Nova--NIKKISO-Europe-GmbH/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FCA-NE-07, 1343/12
  • Acción
    Warning information. Software upgrade.
Notificaciones De Seguridad De Campo acerca de Einstein Vision 3D endoscopy system
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2017-7573
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN20161/Medicinsk-elektriskmekanisk-utrustning--EinsteinVision-3D-endoskopisystem--Scholly-Fiberoptic-GmbH/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    2016_5
  • Acción
    Modification of products. Temporary measures.
Notificaciones De Seguridad De Campo acerca de EkoSonic Controller
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/62387
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2012/Instrument-kirurgi--EkoSonic-Kontrollenhet--EKOS-Corporation/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FSCA dd August 20, 2012
  • Acción
    Instructions for use of products. Modification of instructions.
Notificaciones De Seguridad De Campo acerca de Elecsys Digoxin on cobas e 801 module
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2017-51030
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN20161/In-vitro-diagnostiska-produkter--Elecsys-Digoxin--Roche-Diagnostics-GmbH/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    IO-0000155
  • Acción
    Information on the risk of use. Modification of the manual
Notificaciones De Seguridad De Campo acerca de Elecsys HIV combi PT
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2014-3845
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2014/In-vitro-diagnostiska-produkter--Elecsys-HIV-combi-PT--Roche-Diagnostics-GmbH/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    GC-0599537
  • Acción
    Information on the risk of use. Temporary measures.
Notificaciones De Seguridad De Campo acerca de Elecsys HIV combi PT
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2014-3845
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2014/In-vitro-diagnostiska-produkter--Elecsys-HIV-combi-PT-Roche-Diagnostics-GmbH/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    GC-0599537
  • Acción
    Products should be taken out of service.
Notificaciones De Seguridad De Campo acerca de Elecsys ß-CrossLaps
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2013-39726
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2013/In-vitro-diagnostiska-produkter--Elecsys-B-CrossLaps--Roche-Diagnostics-GmbH/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    IO-0000141
  • Acción
    Modification of the manual.
Notificaciones De Seguridad De Campo acerca de Elecsys TSH and Elecsys PTH Reagent on the cobas e...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2017-9333
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN20161/In-vitro-diagnostiska-produkter--Elecsys-TSH-och-Elecsys-PTH-reagens--Roche-Diagnostics-GmbH/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    CN-301042
  • Acción
    Products should be taken out of service.
Notificaciones De Seguridad De Campo acerca de Elecsys Tyreoglobulin (Tg)
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/77458
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2013/In-vitro-diagnostiska-produkter--Elecsys-Tyreoglobulin-Tg--Roche-Diagnostics-GmbH/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    GC-0522117
  • Acción
    Warning information. Control of the test results.
Notificaciones De Seguridad De Campo acerca de Electric drive unit E-Drive in combination with th...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2017-71178
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN20161/Hjalpmedel-for-funktionshindrade--Elektriskt-drivaggregat-E-Drive-i-kombination-med-rullstol-Etac-Cross-5--Decon-Wheel-AB/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    556618-9006
  • Acción
    Information on the risk of use. Modification of products. Modification of the manual.
Notificaciones De Seguridad De Campo acerca de electric Lift Table
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-98849
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2016/Medicinsk-elektriskmekanisk-utrustning--Elektriskt-lyftbord--IBA-Dosimetry-GmbH/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    CA-2015-009
  • Acción
    Information on the risk of use. Modification of products.
Notificaciones De Seguridad De Campo acerca de Electrically operated hospital beds Multicare and ...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2018-6209
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2018/Hjalpmedel-for-funktionshindrade--Multicare-och-Multicare-LE--Linet-spol-sro/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    V077
  • Acción
    Information on the risk of use. Modification of products.
Notificaciones De Seguridad De Campo acerca de Elegance 3XC
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2011/83645
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2012/Sangar--Eleganza-3XC--Linet/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    –
  • Acción
    Products should be replaced. Instructions on use of the products. Temporary measures.
Notificaciones De Seguridad De Campo acerca de Elekta Synergy XVI R3.5, R4.0, R4.5 and R 4-2
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2011/ 79641
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2012/Utrustning-radiologi--Elekta-Synergy-XVI-R35-R40-R42-och-R45--Elekta/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    A356
  • Acción
    Warning information. Modification of products. Modification of instructions.
Notificaciones De Seguridad De Campo acerca de EliA anti-TSH-R Well
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2018-5041
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2018/In-vitro-diagnostiska-produkter--EliA-anti-TSH-R-Well--Phadia-AB/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    QA2018-01
  • Acción
    Products should be taken out of service.
Notificaciones De Seguridad De Campo acerca de EliA CCP Well and Elijah IgG Conjugate
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2016-32939
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2016/In-vitro-diagnostiska-produkter--EliA-CCP-Well-och-EliA-IgG-Conjugate--Phadia-AB/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    QA2016-02
  • Acción
    Information on the risk of use. Temporary measures.
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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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