Events

Avis De Sécurité sur Lotus™ Valve System

Selon Bundesinstitut für Arzneimittel und Medizinprodukte, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Germany qui a été fabriqué par Boston Scientific International S.A..

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
    02291/15
  • Date
    2015-04-21
  • Pays de l'événement
    Germany
  • Source de l'événement
    BAM
  • URL de la source de l'événement
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2015/02291-15_kundeninfo_en.html
  • Notes / Alertes
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
  • Notes supplémentaires dans les données

Device

Lotus™ Valve System

Manufacturer

Boston Scientific International S.A.
  • 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
    BAM