Events

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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por 3M Health Care; LifeMatrix Technologies.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    390
  • Fecha
    2002-02-15
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    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.
  • Acción
    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