Events

Alerta De Seguridad para GELITACEL GAZE OF OXIDIZED CELLULOSE (Reg. 10369290011) .. Lots committed: 81/07 to 106/07; 109/07; 111/07; 113/07; 114/07; 117/07 to 131/07; 133/07 to 150/07; 153/07 to 163/07.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GELITA MEDICAL B.V..

¿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
    894
  • Fecha
    2007-10-23
  • 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
    According to information from the manufacturer, the problem of insufficient gauze absorption is related to the fact that the defective batches products are more hydrophobic than normal. Such a problem, according to the manufacturer, is not currently identified by the methods of quality control - the company intends to modify some parameters of its tests of absorption and control of raw material, to avoid that the same problem occurs in the future.
  • Causa
    When placed in the surgical site, the oxidized cellulose gauze does not immediately absorb blood from the site.
  • Acción
    The manufacturing company (GELITA MEDICAL BV - NETHERLANDS) has already started a committed batch-picking procedure, initially sending a letter of communication to all its customers and representatives. ORCIMED IND. E COM LTDA, the representative company and holder of the product registration in Brazil, received the manufacturer's communication letter (on 08/10/2007) and informed the Anvisa Technological Monitoring Unit - UTVIG (on 10/18/2007) (20/02/2008): The company that owns the product registration in Brazil (Orcimed Ind. and Com Ltda.) has informed Anvisa that it has collected 5584 product units in the product. Brazil, out of a total of 5880 units (collection of 94.96% of the units under risk). The company informed Anvisa that the collection process is closed.

Device

GELITACEL GAZE OF OXIDIZED CELLULOSE (Reg. 10369290011) .. Lots committed: 81/07 to 106/07; 109/0...

Manufacturer

GELITA MEDICAL B.V.
  • Source
    ANVSANVISA