Events

Safety Alert for Sistema obtryx Transobturator medio-uretral - registered in Anvisa under nº 10341350393

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
    865
  • Date
    2007-04-24
  • 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
    UTVIG awaits return of request of other information, sent to the company.
  • Reason
    Boston scientific do brasil ltda sent a letter to the customers of the referred product, because "it identified that some batches were incorrectly formatted using the model aa / mm (year / month) instead of the format mm / aa (month / year). the "expiration date / product validity" information for the hourglass symbol is correct. however, if the secondary code is scanned, the expiration date information in and directly under the bar code will appear after the current expiration date and will not be in accordance with the information that appears in the "expiration date / ".".
  • Action
    The Company Boston Scientific do Brasil Ltda. has sent a letter to all customers who have received the affected products guiding it is an Important Notice of Medical Product and not a voluntary withdrawal from the product market; this product does not need to be returned to Boston Scientific do Brasil Ltda.

Device

Sistema obtryx Transobturator medio-uretral - registered in Anvisa under nº 10341350393

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA