Alerta De Seguridad para 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.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1193
  • Fecha
    2012-10-10
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la 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.
  • Causa
    User risk attaching the finger while adjusting the height of the chest support bar.
  • Acción
    The company is sending urgent security warning to the customers who purchased the products, with warning stickers to be affixed to the equipment.

Manufacturer