Events

Safety Alert for Hemashield Finesse (reg 10341350305); Hemashield vascular prosthesis in double velvet microvel mesh (reg 10341350330) and Vascular Graft in double velvet fabric (reg 10341350412)

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
    851
  • Date
    2007-01-17
  • 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
    This is voluntary notification made by the company to Anvisa. UPDATES: - 02-15-2007: available at http://www.anvisa.gov.br/tecnovigilancia/alertas/index.htm link
  • Reason
    Problem: boston scientific do brasil ltda reported that "in an area with known excessive moisture and heat, one of our customers lost control of the environment (temperature and humidity) in the area where the hemashields were stored, resulting in the formation of" drops " of the glycerol in the inner blister of the product packaging. the drops appeared in the form of clear, liquid crystalline, water-like spheres. customers opted not to use these products by prolonging the surgery on the patient until a product without drops was located, delaying the surgical procedure in 20 - 30 minutes. " the company reported that "glycerol is one of the materials used in the collagen coverage of hemashield products, and is the source of the observed droplets. exposure of hemashield products to extreme temperature and humidity conditions has been known as a result of this consequence for some time, however, but never before, this has been reported as an impact on patient safety. while (...) "the company has no data" (...) indicating that this condition impacts the clinical performance of the grafts, the presence of glycerol drops indicates that the products were exposed to conditions outside the range of conditions of storage. ".
  • Action
    The Company Boston Scientific do Brasil Ltda. sent a letter to all customers who received the Hemashield products requesting that they "check on their inventory products for similar signs of extreme temperature and humidity exposure, especially if there is a possibility that the product may have been stored outside the conditions mentioned in the If you identify products under the conditions described above, please contact your local sales representative to assist in the return of these units. You should note in the letter that "As indicated in the Instructions for Use of the product, the storage conditions for Hemashield products are "Store in a cool, dry place", "Store in a controlled temperature environment" or "Store at temperatures between 20º and 25º C (68ºF - 77ºF) as defined in the United States Pharmacopeia (USP). If you have questions regarding this material, please contact your local sales representative. "

Device

Hemashield Finesse (reg 10341350305); Hemashield vascular prosthesis in double velvet microvel me...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA