Events

Safety Alert for All products produced by the company Meta Bio Industrial Ltda for valid product registrations, these being: 80034760001; 80034760003; 80034760004; 80034760005; 80034760006; 80034760007; 80034760008; 80034760009; 80034760010; 80034760011; 80034760012; 80034760014; 80034760015; 80034760016; 80034760017; 80034760018; 80034760019; 80034760020; 80034760021; 80034760022; 80034760023; 80034760024; 80034760025; 80034760026; 80034760027; 80034760028; 80034760029; 80034760030; 80034760031; 80034760032; 80034760033; 80034760034; 80034760035; 80034760036; 80034760037; 80034760038; 80034760039; 80034760040; 80034760041; 80034760042; 80034760043; 80034760044; 80034760045; 80034760046; 80034760047; 80034760048; 80034760049; 80034760050; 80034760050; 80034760051; 80034760052; 80034760053; 80034760054; 80034760055; 80034760056; 80034760057; 80034760058; 80034760059; 80034760060; 80034769001

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Meta Bio Industrial 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
    1780
  • Date
    2015-12-21
  • 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 UI, although not in accordance with the latest version of the registry, provides all necessary information regarding the manufacturer's information, indications of use for each type of product / product line, contraindications, special care, postoperative complications, information to the patient, adverse effects, information to the attending physician, conditions and precautions with transportation, handling, storage and preservation, product traceability, product disposal, safe implant removal, identification of product records and all information necessary to that any person or institution can contact Meta Bio or ANVISA via Notivisa. It is important to note that so far there has been no technical complaint, consultation of clients or any health professional questioning the current instructions for use or the content thereof.
  • Reason
    The instructions for use on the products (all registrations) were not in accordance with the latest versions published and approved in their respective anvisa product registers.
  • Action
    a) Risk classification: III b) Classification of the field action: Update, correction or compelmentation of the Instructions for Use c) Field action code: IU / 2015 d) recommendations to users and patients: By publishing the Alert Message Meta Bio, we request that our Distributors disregard the Instructions for Use currently packaged with the products and then consider those published electronically on the Meta Bio website. It is not necessary to follow-up the implanted patients, since the Instruction of Use is not for the lay public and contains information necessary for the due contacts of any type of complaint or adverse event.

Device

All products produced by the company Meta Bio Industrial Ltda for valid product registrations, th...

Manufacturer

Meta Bio Industrial Ltda.