Events

Safety Alert for WALKING R82 - MUSTANG WALKER. Registro Anvisa n ° 80047300401. Serial numbers affected: See complete list at http://portal.anvisa.gov.br/wps/wcm/connect/3007c3804d0787b692c79a551355428f/Lista+de+series+afetadas.pdf?MOD=AJPERES.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO 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
    1193
  • Date
    2012-10-10
  • 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 the product registration holder, warning letters were sent to users and labels with warning of danger - to be affixed to the equipment, close to the point of risk. Action details are displayed in the company's alert message, available at http://portal.anvisa.gov.br/wps/wcm/connect/623b06004d07876192be9a551355428f/Message+of+Alerta+1193.pdf?MOD=AJPERES.## ## Update (02/18/2012): According to information presented by the product registration holder, 19 units of the product were marketed in Brazil, all affected consumers have already been notified by the company and have already received the adhesive labels to be affixed to the equipments. The company also also presented the media plan used to publicize the problem in large circulation media.
  • Reason
    User risk attaching the finger while adjusting the height of the chest support bar.
  • Action
    The company is sending urgent security warning to the customers who purchased the products, with warning stickers to be affixed to the equipment.

Device

WALKING R82 - MUSTANG WALKER. Registro Anvisa n ° 80047300401. Serial numbers affected: See compl...

Manufacturer

MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA.
  • Source
    ANVSANVISA