Events

Safety Alert for CONTOUR MICROPARTICLES OF PVA FOR EMBOLIZATION - Registered in Anvisa under the number 10341350316. Lots - Attached List.

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
    983
  • Date
    2009-09-22
  • 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
    Attached to this notification is a complete listing of all product codes within the scope of this Voluntary Collection. The company is aware that some customers can often remove the product from their carton (secondary packaging) and store it on the stock shelves only in their primary packaging (pouch). If this is a practice in your unit, it is very important that you use the attached product table very carefully, and consider both the UPN code on the primary packaging (pouch) and the secondary packaging (box) when looking for the affected product / product of this voluntary recall, since the UPN numbers on the internal and external labels are different. The product information listed on your Verification and Traceability Response Form (attached in this alert) provides only the UPN codes of the secondary packaging (carton). Anvisa is following this action.
  • Reason
    The company reports that there may be a possibility of compromising the sterile barrier in some packaging. all affected products are packed in a bottle and subsequently in a pouch. the company concluded that the sterile pouch barrier containing the bottle may be ruptured. disruption of sterilization can lead to contamination, which may pose a risk of adverse effects to the patient's health, including, in more extreme cases, septicemia.
  • Action
    The actions recommended to users of the product are as follows: (1) Immediately stop the use of products listed in the attached list; (2) Locate products with the affected models / batches in your inventory and segregate them in a safe place. (3) Complete and return the account verification and traceability response form to Boston Scientific do Brasil Ltda. - A / C Caroline Yin - Fax: (011) 5502-8510; (4) Pack, identify the box with affected products and request collection by calling (011) 5502-8583.

Device

CONTOUR MICROPARTICLES OF PVA FOR EMBOLIZATION - Registered in Anvisa under the number 1034135031...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA