Events

Safety Alert for INSTAT MCH HEMOSTATIC MICROFIBRILLARY COLLAGEN, Model 1984 and 1985, Registration no. 80145900849, lots: 1110786, 1110228, 1110227, 1110785, 1110232, 1105179.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1267
  • Date
    2013-04-23
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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