Events

Alerte De Sécurité sur KIT CONFIDENCE PLUS - Kit Confidence Plus (11 cc) - Record no. 80145901323, lots: HPBB2B, HPBB2G, HPCB7B, HPDBGY, HPDBBL.

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 Ind. e Com. de Prod. 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
    1266
  • Date
    2013-04-22
  • 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
    If the devices have been transferred to other organizations, we ask that you provide the organization's name and contact information on the Field Correction Confirmation Form and forward a copy of this Field Security Notification to the organization to which the device was transferred. If you have further questions or concerns about the information contained in this Field Safety Notice, please contact the representative.
  • Cause
    The company informs that during the injection of cement, water in the hydraulic pump leaks into the pump body after passing through the piston, resulting in loss of pressure and inability to continue to inject cement. this may result in delayed surgery to prepare another kit or to close the procedure earlier than intended, which could result in the patient having to undergo additional anesthesia as a result of another surgical procedure.
  • Action
    The company requests that the above-described combinations of product code and batch number be removed from service and contact your DePuy Synthes Spine * representative to arrange product return, credit and / or replacement. They further request that this information be distributed to relevant personnel in the services, including surgeons who may have received the product, the subject of this notification. See Letter to the Client at: http: //portal.anvisa.gov.br/wps/wcm/connect/4d1748804ff803369991ff6d6e8afaaa/KIT_CONFIDENCE_PLUS_FORMULARIO_DE_CONFIRMACAO_2_.pdf? MOD = AJPERES

Device

KIT CONFIDENCE PLUS - Kit Confidence Plus (11 cc) - Record no. 80145901323, lots: HPBB2B, HPBB2G,...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda