Events

Safety Alert for Trade name: ANCORA DE REINSERÇÃO CQR. Technical Name: Implant for Ligament. ANVISA registration number: 80519830007. Risk class: III - High Risk. Model affected: I.6 MM

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by TARGMED COM. E IMPORT. DE PROD. MÉD. E HOSP. LTD; TRANSYSTÈME S.A..

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
    2018
  • Date
    2016-10-25
  • 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
    The surgeon must observe the correct technique described in the instructions for use of the product. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    Received complaint by the company, in which the customer reports the product break. when analyzing the description of the occurrence, it was concluded that the surgical technique used in this procedure is not in accordance with the instruction of use. the correct technique is to use the initiator (wire) 2.5 mm, the surgeon used 1.5 mm. carrying the product break. the instruction of use was sent and all clarifications were given about the use of the product during the sale of the same.
  • Action
    Field Action Code 2016.09.002925 triggered under the responsibility of the company TARGMED COM. AND IMPORT. OF PROD. MÉD. AND HOSP. LTDA - FANTASY NAME: IMPORTEK. The company will carry out training to strengthen the surgical technique guidelines described in the Instructions for Use of the product.

Device

Trade name: ANCORA DE REINSERÇÃO CQR. Technical Name: Implant for Ligament. ANVISA registration n...

Manufacturer

TARGMED COM. E IMPORT. DE PROD. MÉD. E HOSP. LTD; TRANSYSTÈME S.A.
  • Source
    ANVSANVISA