Events

Alerta De Seguridad para THOMPSON INCOMEPE QUADRIL PARTIAL PROTESIS - Record 10395270006 - Batch 013921 MODELS: (Reference / Diameter) 3003900 / Ø39; 3004100 / Ø41; 3004300 / Ø43; 3004500 / Ø45; 3004700/4747; 3004900 / Ø49; 3005100 / Ø51; 3005300 / Ø53.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por INCOMEPE INDÚSTRIA DE MATERIAIS CIRÚRGICOS LTDA..

¿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
    1068
  • Fecha
    2011-07-15
  • 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
    Alert ended 2/4/2013. SEE ALERTS OF TECNOVIGILANCE N ° 1213 E 1231.
  • Causa
    By determination of anvisa (re 2,333, of may 30, 2011 - dou 103 of 05/31/2011) affected products must be collected from the market. tests carried out identified quality deviations in the raw material and in the product manufacturing process.
  • Acción
    Healthcare establishments or distributors holding the affected product batch shall act as follows: (1) Suspend the use (in the case of health facilities) or marketing (in the case of distributors) of the product; (2) segregate and identify affected products so that they are not inadvertently used; (3) In the case of affected products already implanted, the patient's data, the dates of the surgeries and the name of the responsible doctors were requested.

Device

THOMPSON INCOMEPE QUADRIL PARTIAL PROTESIS - Record 10395270006 - Batch 013921 MODELS: (Reference...

Manufacturer

INCOMEPE INDÚSTRIA DE MATERIAIS CIRÚRGICOS LTDA.
  • Source
    ANVSANVISA