Events

Safety Alert for Commercial Name: HELOSENTIC COLLAGEN AGENT HELITENE - Models: (i). 1692-ZK (Lot 1112217); (ii). 1692-ZL (Batch 1105255, 1111601). . Registration number with ANVISA: 10099430085. Risk Class: IV - MAXIMUM RISK. Validity Record: 12/27/2016

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by INTEGRA LIFECIENCES COR.

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
    1263
  • Date
    2013-04-27
  • 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 reported that it has received no communication that any patient has been harmed or has suffered any damage by using these batches of the product. Contact: Robson Pereira - Quality Coordinator - Dabasons Imp. Exp. And Com. Ltda. Phone: (11) 3371-1586.
  • Reason
    # lots with endotoxin levels above that specified for the product # # due to the batch process deviations from the products they may have been released with higher levels of endotoxin than allowed by the product specifications, despite having been subjected to all tests of finished products, have been tested and accepted in the endotoxin level tests. according to the company, they are sterile. # possible consequences of using the affected product: "higher levels of endotoxin may result in fever in the postoperative period.".
  • Action
    The company is collecting the lots at risk and sent a letter to the customers with the following guidelines (Text as original of the company): "1. Verify that you have any batch of the product mentioned on the next page and if you have, - 2. Remove this product from stock or customer - 3. Fill in the return form on the next page - Ship to Dabasons as instructed on the form - 4. Our customer service will contact you to replace the product. product returned. " In addition, he reported that if the product has already been implanted or used the collagen sponge of the products affected by the Field Action, the patient should be monitored for fever in the postoperative period. In this case, the hospital or clinic standards must be followed. In the event of an adverse effect of this nature, the company should be contacted by telephone number, a Please notify us about any adverse effect of this nature in the number below.

Device

Commercial Name: HELOSENTIC COLLAGEN AGENT HELITENE - Models: (i). 1692-ZK (Lot 1112217); (ii). 1...

Manufacturer

INTEGRA LIFECIENCES COR