Events

Avis De Sécurité sur Pulsar-18, Peripheral self-expanding Nitinol stent system

Selon Health Sciences Authority (HSA), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Singapore qui a été fabriqué par Biotronik Asia Pacific Pte Ltd.

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
    600:41/01-269/18/01_37
  • Date
    2018-04-09
  • Pays de l'événement
    Singapore
  • Source de l'événement
    HSA
  • URL de la source de l'événement
    https://www.hsa.gov.sg/announcements
  • Notes / Alertes
    Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), 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 recall data from the U.S. and Singapore.
  • Notes supplémentaires dans les données
    Biotronik AG

Device

Pulsar-18, Peripheral self-expanding Nitinol stent system
  • Modèle / numéro de série
  • Description du dispositif
    Pulsar-18, Peripheral self-expanding Nitinol stent system, Biotronik AG
  • Manufacturer
    Biotronik Asia Pacific Pte Ltd

Manufacturer

Biotronik Asia Pacific Pte Ltd
  • Société-mère du fabricant (2017)
    Ms Holding Ii Se
  • Commentaire du fabricant
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    HSAHSA