Events

Avis De Sécurité sur Lynx™ System, Suprapubic Sling, Obtryx™ System

Selon Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Czechia qui a été fabriqué par Boston Scientific Corporation.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    628
  • Date
    2016-06-29
  • Pays de l'événement
    Czechia
  • Source de l'événement
    MHSIDCCCDMIS
  • URL de la source de l'événement
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notes / Alertes
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
  • Notes supplémentaires dans les données

Device

Lynx™ System, Suprapubic Sling, Obtryx™ System
  • Modèle / numéro de série
    Model Number: viz seznam soucasti FSN Product Description UPN AdvantageTM System M0068502000 AdvantageTM System, 5-Pack M006850200051 Advantage FitTM System M0068502110 Advantage FitTM System, 5-Pack M0068502111 LynxTM System M0068503000 LynxTM System, 5-Pack M0068503001 ObtryxTM System, Curved M0068504000 ObtryxTM System, Curved 5-Pack M0068504001 ObtryxTM System, Halo M0068505000 ObtryxTM System, Halo 5-Pack M0068505001 ObtryxTM II System with PrecisionBlueTM Design, Curved M0068504110 ObtryxTM II System with PrecisionBlueTM Design, Curved 5-Pack M0068504111 ObtryxTM II System with PrecisionBlueTM Design, Halo M0068505110 ObtryxTM II System with PrecisionBlueTM Design, Halo 5-Pack M0068505111 Solyx™ SIS System M0068507000 Solyx™ SIS System, 5-Pack M0068507001 UpholdTM LITE Vaginal Support System with CapioTM SLIM M0068318170 PinnacleTM LITE Pelvic Floor Repair Kit, Posterior with CapioTM SLIM M0068318150 UpsylonTM Y Mesh Kit with ColpassistTM Vaginal Positioning Device M0068318220 Product Description UPN XenformTM Soft Tissue Repair Matrix, 2cm x 7cm M0068302410 XenformTM Soft Tissue Repair Matrix, 4cm x 7cm M0068302430 XenformTM Soft Tissue Repair Matrix, 6cm x 10cm M0068302450 XenformTM Soft Tissue Repair Matrix, 8cm x 12cm M0068302470
  • Description du dispositif
    Inactive implantable medical devices
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    MHSIDCCCDMIS