Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by INCOMEPE INDÚSTRIA DE MATERIAIS CIRÚRGICOS LTDA..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1068
  • Date
    2011-07-15
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Alert ended 2/4/2013. SEE ALERTS OF TECNOVIGILANCE N ° 1213 E 1231.
  • Reason
    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.
  • Action
    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