Events

Avis De Sécurité sur Capio™ SLIM Suture Capturing Device, Capio™ SLIM Suture Capturing Device (Box 5), Capio™ Open Access Suture Capturing Device (Box 4), Capio™ Standard Suture Capturing Device (Box 4), Capio™ RP Suture Capturing Device, Uphold™ LITE with Capio™ SLIM Vaginal Support System, Pinnacle™ Anterior Pelvic Floor Repair Kit, Pinnacle™ LITE Posterior with Capio SLIM Pelvic Floor Repair Kit

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
    1485
  • Date
    2018-03-16
  • 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

Capio™ SLIM Suture Capturing Device, Capio™ SLIM Suture Capturing Device (Box 5), Capio™ Open Acc...
  • Modèle / numéro de série
    Model Number: Capio™ SLIM Suture Capturing Device M0068318250 Capio™ SLIM Suture Capturing Device (Box 5) M0068318261 Capio™ Open Access Suture Capturing Device (Box 4) M0068311251 Capio™ Standard Suture Capturing Device (Box 4) M0068312321 Capio™ RP Suture Capturing Device M0068321010 Uphold™ LITE with Capio™ SLIM Vaginal Support System M0068318170 Pinnacle™ Anterior Pelvic Floor Repair Kit M0068317050 Pinnacle™ LITE Posterior with Capio SLIM Pelvic Floor Repair Kit M0068318150
  • 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