Hemashield Finesse (reg 10341350305); Hemashield vascular prosthesis in double velvet microvel mesh (reg 10341350330) and Vascular Graft in double velvet fabric (reg 10341350412) 의 안전성 경고

Safety alert

851

2007-01-17

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

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. ".

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. "