Events

Alerte De Sécurité sur Surgical Surgical Lens, Registration nº 10201230077 - Lots 2149701; 2149801; 2299701; 2149802; 2299702; 2149803; 2149804; 2149805; 2299703; 2149707; 2149712; 2149807; 21498

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 Embramac- Empresa Brasileira de Materiais Cirúrgicos, Indústria, Comércio, Importação e Exportação Ltda; Terang Nusa SDN BHD.

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
    1429
  • Date
    2014-09-26
  • 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
    The factory audit performed within the maintenance process of the Seal of Identification of Conformity demonstrated that the company changed the sterilization process for the product, being in disagreement with the information sent to ANVISA.////////// UPDATE: The company completed the field action, according to report sent on the date of 01/29/2015.
  • Cause
    Suspension of authorization for the use of the conformity identification seal by the product certification body (ocp) motivated by the factory audit where it was noted that the surgical gloves were sterilized by a different method from the product registration.
  • Action
    Company shall initiate Field Action for the collection of products manufactured from the date of the last factory audit, held on April 23 and 24, 2014.

Device

Surgical Surgical Lens, Registration nº 10201230077 - Lots 2149701; 2149801; 2299701; 2149802; 22...

Manufacturer

Embramac- Empresa Brasileira de Materiais Cirúrgicos, Indústria, Comércio, Importação e Exportaçã...