• Acerca de la base de datos
  • ¿Cómo usar la IMDD?
  • Descargar la data
  • Preguntas frecuentes
  • Créditos
Vista de la lista Vista de las tarjetas
  • Dispositivo 3
  • Fabricante 3
  • Evento 124969
  • Implante 0
Notificaciones De Seguridad De Campo acerca de Accu-Chek Spirit Combo and Accu-Chek Spirit
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-33582
  • 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/Medicinsk-elektriskmekanisk-utrustning--Accu-Chek-Spirit-Combo-och-Accu-Chek-Spirit--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
    2218/15, SB_RDC_2015_02
  • Acción
    Information on the risk of use. Modification of the manual
Notificaciones De Seguridad De Campo acerca de ACCURUN 51 positive control for Hepatitis several ...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2017-51552
  • 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--ACCURUN-51-positiv-kontroll-for-hepatit-flera-markorer--SeraCare-Life-Sciences/#
  • 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
    EU7A51_B
  • Acción
    Information on the risk of use.
Notificaciones De Seguridad De Campo acerca de Accurus vitrectomy probe
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-49601
  • 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/Medicinsk-elektriskmekanisk-utrustning--Accurus-vitrectomiprober--Alcon-Laboratories-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
    2015.026
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de Accutrend BM-Lactate test strips
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2013-2402
  • 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--Accutrend-BM-Lactate-testremsor--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-0540100
  • Acción
    Products should be discarded.
Notificaciones De Seguridad De Campo acerca de ACE Control
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2014-6048
  • 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--ACE-Kontroll--Trinity-Biotech/#
  • 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
    R001-14
  • Acción
    Modification of products.
Notificaciones De Seguridad De Campo acerca de ACETABULAR CUP INTRODUCER (32 mm)
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2017-80726
  • 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/Flergangsprodukter--ACETABULAR-CUP-INTRODUCER--DePuy-International-Ltd/#
  • 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
    PIE 746814
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de Acetaminophen reagent
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-38815
  • 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/Rubrik-In-vitro-diagnostiska-produkter--Acetaminophen-reagens--Sekisui-Diagnostics-PEI-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
    ACET 2K99-20 20150507
  • Acción
    Modification of the manual.
Notificaciones De Seguridad De Campo acerca de Acetaminophen reagent
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-38815
  • 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/In-vitro-diagnostiska-produkter--Acetaminophen-reagens--Sekisui-Diagnostics-PEI-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
    ACET 2K99-20 20150507
  • Acción
    Modification of the manual.
Notificaciones De Seguridad De Campo acerca de Acetaminophen reagent
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2016-6037
  • 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--Acetaminophen-reagens--Sekisui-Diagnostics-PEI-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
    ACET-506-2016-01-22 (Sekisui Ref.), FA25JAN2016 (Abbott Ref.)
  • Acción
    Information on the risk of use. Products should be taken out of service. Modification of labeling.
Notificaciones De Seguridad De Campo acerca de Acetocaustin
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2012-122756
  • 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/Engangsartiklar--Acetocaustin--Temmler-Pharma-GmbH--Co-KG/#
  • 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
    Information on the risk of use.
Notificaciones De Seguridad De Campo acerca de ACL Top Family instruments
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2014-65934
  • 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--ACL-Top-Family-instrumenten--Instrumentation-Laboratory-Co/#
  • 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 2014_001_C
  • Acción
    Information on the risk of use.
Notificaciones De Seguridad De Campo acerca de ACP215 automated cell processor, MCS + 9000 mobile...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2016-9481
  • 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--ACP215-MCS9000-MCS8150-och-PCS2--Haemonetics-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
    DR115222
  • Acción
    Information on the risk of use. Modification of the manual
Notificaciones De Seguridad De Campo acerca de ACQUITY Sample Holder
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/20548
  • 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/IVD-produkter--ACQUITY-Provhallare---Waters/#
  • 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
    1218959-03/14/2012-003-C
  • Acción
    Warning information. Modification of products.
Notificaciones De Seguridad De Campo acerca de ACQUITY TQD, ACQUITY SQD, LCT Premier XE, Quattro ...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/80328
  • 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/IVD-produkter--ACQUITY-TQD-ACQUITY-SQD-LCT-Premier-XE-Quattro-Premier-Quattro-Premier-XE-Quattro-micro-Xevo-G2-Tof-Xevo-TQ-Xevo-TQD-och-ZQ-2000--Waters-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
    1218959-10/18/2012-006-C
  • Acción
    Modification of products.
Notificaciones De Seguridad De Campo acerca de Acquity TQD, SQD and 3100 spectrometers
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2011/35304
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2011/IVD-produkter--Acquity-TQD-SQD-och-3100-masspektrometrar--Waters/#
  • 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
    1218959-05/03/2011-002-C
  • Acción
    Modification of products.
Notificaciones De Seguridad De Campo acerca de ACQUITY UPLC sample sorter
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2017-29240
  • 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--ACQUITY-UPLC-provsorterare--Waters-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
    1218959-04/10/2017-001-C
  • Acción
    Information on the risk of use. Modification of products.
Notificaciones De Seguridad De Campo acerca de ACRYSOF Cachet facial lens
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/11037
  • 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/PRODUKTGRUPP--ACRYSOF-Cachet-fakisk-lins--Alcon-Laboratories/#
  • 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
    06.02.2012
  • Acción
    Modification of instructions.
Notificaciones De Seguridad De Campo acerca de AcrySof IQ IOL with ULTRASERT Delivery System
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2016-62632
  • 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/Implantat--AcrySof-IQ-IOL-med-ULTRASERT-Delivery-System--Alcon-Laboratories-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
    2016.069
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de AcrySof IQ IOL with ULTRASERT Delivery System
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2016-62632
  • 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--AcrySof-IQ-IOL-with-ULTRASERT-Delivery-System--Alcon-Laboratories-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
    2016.069
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de ACS NT, Intera 1.5T- and Achieva 1.5T MR systems w...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-60897
  • 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/Diagnostiska-och-behandlande-stralningsprodukter--ACS-NT--Intera-15T-och-Achieva-15T-MR-system-med-SENSE-kroppsspole-15T--Philips-Medical-Systems-Nederland-BV-/#
  • 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
    FCO781 00437
  • Acción
    Information on the risk of use. Modification of products.
Notificaciones De Seguridad De Campo acerca de AcSelerate manually tripod (software version 1.2 a...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2011/90304
  • 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--AcSelerate---Fujifilm/#
  • 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
    2011-E-0412
  • Acción
    Warning information. Instructions on use of the product. Software upgrade.
Notificaciones De Seguridad De Campo acerca de Actifuse ABX
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2015-71162
  • 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/Implantat--Actifuse-ABX--ApaTech-Limited/#
  • 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-2015-071
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de ACTIFUSE MIS and ACTIFUSE ABX synthetic bone subst...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/65138
  • 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/Implantat-ortopedi--ACTIFUSE-MIS-och-ACTIFUSE-ABX--ApaTech-Limited/#
  • 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-2012-061
  • Acción
    Modification of instructions.
Notificaciones De Seguridad De Campo acerca de Actim CRP-measuring sticks
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2014-24054
  • 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--Actim-CRP-matstickor--Oy-Medix-Biochemica-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
    CRP 2014-02-26
  • Acción
    Products should be revoked.
Notificaciones De Seguridad De Campo acerca de Activa PC, Activa PC + S, Activa RC, Activa SC, al...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2014-13155
  • 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/Aktiva-implantat--Activa-PC-Activa-PCS-Activa-RC-Activa-SC-alla-Restore-produkter-inklusive-SureScan-PrimeADVANCED-PrimeADVANCED-SureScan-MRI-och-Itrel-4--Medtronic-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
    FA593
  • Acción
    Information on the risk of use. Modification of the manual
  • « First
  • ‹ Prev
  • 1
  • 2
  • 3
  • 4
  • 5
  • …
  • Next ›
  • Last »

Acerca de la base de datos

Explore más de 120,000 registros de retiros, alertas y notificaciones de seguridad de dispositivos médicos y sus conexiones con los fabricantes.

  • Preguntas frecuentes
  • Acerca de la base de datos
  • Contáctenos
  • Créditos

Historias en su correo

¿Trabaja en la industria médica? ¿O tiene experiencia con algún dispositivo médico? Nuestra reportería no ha terminado. Queremos oír de usted.

¡Cuéntanos tu historia!

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.

Descargar la data

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.

Descargar todo (zipped)