Events

Safety Alert for BROCKENBROUGHT ADULT NEEDLE. ANVISA Registration No. 10339190097 ;. BROCKENBROUGHT PEDIATRIC NEEDLE. ANVISA Registration No. 1033919009.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDTRONIC COMERCIAL 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
    1239
  • Date
    2013-04-03
  • 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 effectively started the field action on 03/22/2013, with code FA-570. For additional clarification please refer to Resolution Anvisa RE n ° 4,856 of November 12, 2012, available at http://portal.anvisa.gov.br/wps/wcm/connect/5c18c0004f214e56b56fbdc88f4b6a31/RE_4.8562_2012.pdf?MOD=AJPERES . #### Update (07/26/2013): The company reported having collected a total of 49 units of the products at risk (termination of action on 07/24/2013).
  • Reason
    Problems related to product sterility.
  • Action
    Suspension throughout the national territory of the importation, disclosure, distribution, marketing and use of all lots of the aforementioned products, as well as the collection of all its existing units in the market.

Device

BROCKENBROUGHT ADULT NEEDLE. ANVISA Registration No. 10339190097 ;. BROCKENBROUGHT PEDIATRIC NEED...

Manufacturer

MEDTRONIC COMERCIAL LTDA
  • Source
    ANVSANVISA