Events

Safety Alert for KNEE KNEE FOR TRACHEOSTOMY WITH BALLOON SHILEY MALLINCKRODT. Affected models: 8LPC and 8FEN. Registro Anvisa n ° 10139810076. Lots affected: consult http://portal.anvisa.gov.br/wps/wcm/connect/b285ed004c0c8c7b90e6d0dc39d59d3e/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 MALLINCKRODT DO BRASIL LTD.

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
    1151
  • Date
    2012-07-20
  • 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
    According to Mallinckrodt's information, the problem in question has the potential to cause serious adverse events, because in the event of a cannula leak ventilation to the patient can be seriously compromised. Additional information available at: http://portal.anvisa.gov.br/wps/wcm/connect/cf361b004c0c8ca390efd0dc39d59d3e/Messaje+de+Alerta.pdf?MOD=AJPERES #### UPDATE (25/09/2012): A company sent a field action monitoring report, reporting that it has collected 556 product units so far, out of a total of 6,982 units marketed in Brazil. #### UPDATE (11/30/2012 and 1/30/2013): The company sent monitoring reports with information similar to previous monitoring reports (556 units collected, out of a total of 6,982 units marketed). #### UPDATE (03/28/2013): The second most recent monitoring report, the company reported that it has collected 655 product units so far.
  • Reason
    Possibility of leakage or disconnection between the inner and outer cannulae.
  • Action
    Mallinckrodt is collecting the affected lots. Identify affected products in use and replace them as soon as possible with clinically appropriate products. If this substitution is not possible, increase the patient's direct observation frequency to monitor any problems. Check your inventory and segregate the affected products by identifying them to avoid their use. Fill out and return the Customer Return Form to Mallinckrodt Ltda. If necessary, please contact the company for additional information on how the products collected should be forwarded. Customer Return Form available at http://migre.me/9YCbV (shortened).

Device

KNEE KNEE FOR TRACHEOSTOMY WITH BALLOON SHILEY MALLINCKRODT. Affected models: 8LPC and 8FEN. Regi...

Manufacturer

MALLINCKRODT DO BRASIL LTD