Events

Safety Alert for EXTRACT OF SURGICAL CLAMPS PROXIMATE * - Record 10132590054 - Lots Affected - See annex .. http://portal.anvisa.gov.br/wps/wcm/connect/19c0fb004d632634b56bf5c116238c3b/Lotes_Afetados.pdf?MOD=AJPERES

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
    1197
  • Date
    2012-11-09
  • 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
    Ethicon Endo-Surgery has initiated a voluntary recall of all PSX Proximate® Skin Staple Extractors products because of the possibility that damage to the packaging may have compromised the sterility of the product. The problem was detected internally during the packaging process. No customer complaints related to this issue were received, as well as no adverse event reports associated with the product under recall. Ethicon Endo-Surgery has stopped production and shipment of the affected product and is investigating the root cause of the packaging problem and will implement actions to resume production. There are no notifications to date in the NOTIVISA system. Anvisa follows this action.
  • Reason
    Possibility of compromising the sterile barrier of the package.
  • Action
    Users are advised to: See annex. http://portal.anvisa.gov.br/wps/wcm/connect/35191e004d6326a7b574f5c116238c3b/Carta_aos_Hospitais.pdf?MOD=AJPERES 1. Inspect your inventory immediately to see if you have the affected product, and separate those products. View detailed images to help identify affected products. 2. Fill out the Business Response Form and fax it to (11) 3030-1109 or return it to your local sales representative within 3 business days of receiving this notice, even if you do not have the product affected. Mention Event 5928. If you have any product to be returned, keep a copy of this form in your records. 3. To return the affected product, take a xerox copy of the completed Business Response Form, place it in the box along with your product, and attach the pre-printed shipping label and mail it to the company's local warehouse. 4. Share this information with all appropriate personnel in your facility. 5. As for any medical device, adverse reactions or quality problems, occurring in the use of this product, may be reported to the local representative.

Device

EXTRACT OF SURGICAL CLAMPS PROXIMATE * - Record 10132590054 - Lots Affected - See annex .. http:/...

Manufacturer

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