Events

Alerte De Sécurité sur Dialisador CA 210, Lot: A01C04

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 Baxter Hospitalar Ltda..

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
    756
  • Date
    2003-11-11
  • 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
    Baxter Hospitalar Ltda reports that: "Previous reports of a similar nature have been associated with the use of dialysers with unmodified cellulose acetate fiber. It is not known to what extent the time and / or storage conditions of the dialysers influence this type of incident. In Brazil we have not received any reports of Red-Eye Syndrome using these dialysers. "///// If your EAS received the batch in question, immediately suspend the use and contact the Manufacturer or your local representative. The Tecnovigilância / ANVISA Unit will be monitoring all actions carried out by the company.
  • Cause
    Reports received from a dialysis clinic in mexico, where 10 patients reported adverse events including conjunctivitis, iritis, malaise, myalgia, and arthralgia combined. these events are related to the syndrome known as "red eye syndrome".
  • Action
    BRAZIL - 11.11.2003 - Baxter Hospitalar Ltda is initiating the voluntary withdrawal of the A01C04 lot from the dialyzer CA 210 by means of a letter dated 11.11.2003.

Device

Dialisador CA 210, Lot: A01C04

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA