Events

Safety Alert for Trade Name: Protesica Intracorp Screen Technical Name: Polypropylene Screen ANVISA Registration Number: 10366900008 Hazard Class: III Affected Model: 6 CM X 12 CM Serial Numbers Affected: Code 05010002 - lot T12550

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by VENKURI INDUSTRIA DE PRODUTOS MÉDICOS 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
    2287
  • Date
    2017-05-15
  • 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
    Verification of stock availability of the indicated lot; Discontinuation of the use of the units of this lot; Return of all units of this lot to Venkuri Indústria de Produtos Médicos Ltda.
  • Reason
    The stitch of the weft is hindering the fixation and usability of the product by the doctor during the surgical procedure.
  • Action
    Field Action Code 001.17 triggered under the responsibility of the company VR VENKURI INDUSTRIA DE PRODUTOS MÉDICOS LTDA. Company will collect for further destruction.

Device

Trade Name: Protesica Intracorp Screen Technical Name: Polypropylene Screen ANVISA Registration N...

Manufacturer

VENKURI INDUSTRIA DE PRODUTOS MÉDICOS LTDA.