Events

Alerte De Sécurité sur GYNECARE MORCELLEX FABRIC CLEANER. MODEL: MX0100. Registro Anvisa 80145901131. Lots affected: See annex at http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/994_lotes_afetados.pdf.

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 Johnson & Johnson do Brasil Indústria e Comércio de Produtos para Saúde Ltda..

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
    994
  • Date
    2009-10-29
  • 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
    According to Johnson & Johnson do Brasil, there has still been no record of adverse event related to the problem. If the "duckbill" seal detaches from the morcellator and is allowed to remain inside a patient, there is the possibility of adhesions formation, secondary pain to the formation of adhesions, erosion to the organs of the abdominal cavity with possible subsequent hemorrhage and / or sepsis and obstruction secondary to adhesion formation. Anvisa's Technovigilance Unit is monitoring this case.
  • Cause
    A piece of the product (sealing "duck-beak") may come off during a surgical procedure and remain inside the patient.
  • Action
    The necessary actions are as follows: (1) Check in your stock if you have affected products; (2) Segregate affected products by visually identifying them with a label; (3) Contact the product registration holder (Johnson & Johnson do Brasil Ltda.) Or an authorized distributor for the return of the material. The use of affected products in stock must cease immediately.

Device

GYNECARE MORCELLEX FABRIC CLEANER. MODEL: MX0100. Registro Anvisa 80145901131. Lots affected: See...

Manufacturer

Johnson & Johnson do Brasil Indústria e Comércio de Produtos para Saúde Ltda.