Events

Safety Alert for MEDITATION SHOULDER. Anvisa Registry No. 10341350592. Affected lots: 11B15B6, 11B23B7, 11C09BA and 11C16B9.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Boston Scientific do Brasil 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
    1101
  • Date
    2011-11-25
  • 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
    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. ####
  • Reason
    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