Events

Alerte De Sécurité sur InterGard Knitted Silver IGK 1407S Prosthesis - Series 8260121 - Lot 02C29

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par INTERVASCULAR.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    677
  • Date
    2002-09-02
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    Brazil 04.08.2002- Existence of an affected product in Brazil. INTERVASCULAR - USA issued a notice of correction on September 2 to POLITEC IMPORT & TRADE LTDA-Brazil, requesting that it state whether the product was in stock or consigned in a hospital or if it had been implanted. ANVISA through the Technovigilance Unit contacted the representative in Brazil (POLITEC IMPORTAÇÃO E COMÉRCIO LTDA) and it informed that the said product was in stock and the blocking was provided, informing the manufacturer (INTERVASCULAR US ) of the action taken. On 20.09.2002, they received authorization from the manufacturer for the return of the product that was sent by DHL on 09.29.2002, closing the whole process.
  • Cause
    Labeling error - intgergard knitted silver igk 1407s is incorrectly labeled on the cardboard box with the serial number 8260121, while on the outer plastic protective packaging (blister), and in the aluminum bag is correctly labeled serial number 826022.
  • Action
    Letter of notification of correction sent to the representative / distributor in Brazil.

Device

InterGard Knitted Silver IGK 1407S Prosthesis - Series 8260121 - Lot 02C29

Manufacturer

INTERVASCULAR
  • Source
    ANVSANVISA