Events

Safety Alert for BEAD BLOCK MICRO-SPHERE FOR BOILING. Anvisa Registry n ° 80012280078. Models under risk: Bead Block 100-300 micrometers and 300-500 micrometers.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Terumo Medical do Brasil Ltda.; Biocompatibles UK LTD.

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
    1523
  • Date
    2015-03-09
  • 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
    Suppliers and health care facilities using this product should alert product users to incorrect product information on the product label, thus avoiding the possible (incorrect) use of spheres with diameters of less than 500 micrometers in the case of uterine fibrosis. The information in the Instructions for Use is correct as to the indication of use of the product.
  • Reason
    Incorrect product labeling in english stating that product sizes 100-300μm and 300-500μm can be used for uterine fibrosis (when in fact only products of size 500-700μm, 700-900μm and 900- 1200 μm are indicated for uterine fibrosis).
  • Action
    The company has already started communicating the problem to its suppliers and customers. Users of the product should pay attention to the information contained in the Product Use Instructions, which are correct. See the alert message at: http://portal.anvisa.gov.br/wps/wcm/connect/c5073c0047951ed683cbebfe096a5d32/Community+Access+of+Camp .pdf? MOD = AJPERES

Device

BEAD BLOCK MICRO-SPHERE FOR BOILING. Anvisa Registry n ° 80012280078. Models under risk: Bead Blo...

Manufacturer

Terumo Medical do Brasil Ltda.; Biocompatibles UK LTD
  • Source
    ANVSANVISA