Events

Alerte De Sécurité sur MEDITATION SHOULDER. Anvisa Registry No. 10341350592. Affected lots: 11B15B6, 11B23B7, 11C09BA and 11C16B9.

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 Boston Scientific do Brasil 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
    1101
  • Date
    2011-11-25
  • 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
    Boston Scientific became aware, through customer complaints, that the 0.035 "internal diameter dilator (ID) may have been mislabeled as a 0.038" dilator. According to the company, injuries are not expected to occur as a result of this incorrect labeling, as it would not be possible to advance the dilator through the guidewire. Due to the exchange of labeling, there may be a delay in the procedure during the exchange of devices by the surgeon. #### UPDATE - 02/24/2012 - The company forwards the final report of the field action, declaring the total collection of the affected and forwarded products to the manufacturer. ####
  • Cause
    Incorrect labeling of product dilator - 0.0035 "internal diameter dilator labeled 0.0038".
  • Action
    The product registration holder has already started collecting the product. Health facilities should remove all affected products from their stocks, segregate them in a safe place and identify them properly so that they are not inadvertently used. The affected products will be collected by Boston Scientific do Brasil Ltda or its distributors.

Device

MEDITATION SHOULDER. Anvisa Registry No. 10341350592. Affected lots: 11B15B6, 11B23B7, 11C09BA an...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA