Events

Alerte De Sécurité sur INSTAT MCH HEMOSTATIC MICROFIBRILLARY COLLAGEN, Model 1984 and 1985, Registration no. 80145900849, lots: 1110786, 1110228, 1110227, 1110785, 1110232, 1105179.

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
    1267
  • Date
    2013-04-23
  • 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 company reports that higher levels of endotoxin may result in fever in the immediate postoperative period. At this time the company is not aware of reports of patient injury or other adverse events in relation to these batches of products. However, it advises that if the service has already implanted or used the collagen sponges affected by this recall, the patient is monitored for fever in the immediate postoperative period according to the standard hospital or clinical protocol.
  • Cause
    The registrant reports that integra lifesciences has detected through a quality assurance review that some of the processes may have deviated from the production process during the manufacture of specific batches of the product. batches of the product in question have been approved in all tests for finished products, are sterile and have been tested and accepted for endotoxin levels. however, due to process drift, they may have been released with higher levels of endotoxin than allowed by product specifications. according to the company's assessment, higher levels of endotoxin may result in fever in the immediate postoperative period. we are not aware of reports of patient injuries or other adverse events in relation to these batches of products.
  • Action
    1. Make sure you have some of the batches listed on the next page and if so, stop using the product. 2. Remove the service product. 3. Complete the Return Confirmation Form and send this form to the representative. 4. The Customer Service department will contact you for return and replacement of the product. See Letter to the Client at: http: //portal.anvisa.gov.br/wps/wcm/connect/98287d004ff8045699a4ff6d6e8afaaa/Carta_ao_cliente_Instat_MCH.pdf? MOD = AJPERES

Device

INSTAT MCH HEMOSTATIC MICROFIBRILLARY COLLAGEN, Model 1984 and 1985, Registration no. 80145900849...

Manufacturer

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