Events

Alerte De Sécurité sur Healing Tegagel Hydrogel, in Tubes. Catalog No. 90412; Lot nº 6104101 Valid until May 2003

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 3M Health Care; LifeMatrix Technologies.

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
    390
  • Date
    2002-02-15
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    The tegagel tube above was filled by a similar product substance, the hollister restore hydrogel formulation, which has many of the same ingredients. the distributor initiated a correction by letter dated october 4, 2001. the firm received no customer complaints about the affected lot.
  • Action
    Verify that you received the letter dated October 4, 2001 and the replacement order for 3M Health Care. Identify and isolate any affected product in your inventory. Complete the replacement form, and identify the quantity of products, both open and closed, to be replenished. If you do not have this product in your inventory, indicate it on the form. Fax the completed form to your local 3M representative. When 3M has received the completed form, a return authorization will be issued and the planning will be done to withdraw the product. For more information, contact your local 3M Health Care representative. . ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory.

Device

Healing Tegagel Hydrogel, in Tubes. Catalog No. 90412; Lot nº 6104101 Valid until May 2003

Manufacturer

3M Health Care; LifeMatrix Technologies
  • Source
    ANVSANVISA