Events

Alerte De Sécurité sur BEAD BLOCK MICRO-SPHERE FOR BOILING. Anvisa Registry n ° 80012280078. Models under risk: Bead Block 100-300 micrometers and 300-500 micrometers.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Terumo Medical do Brasil Ltda.; Biocompatibles UK LTD.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1523
  • Date
    2015-03-09
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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