Events

Alerte De Sécurité sur 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.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1193
  • Date
    2012-10-10
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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