BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURO-MED GAM STERILE BURN BLANKET

    MDR report key: 6572188 · Received May 15, 2017

    Report

    Report Number
    MW5069810
    Event Type
    Injury
    Date Received
    May 15, 2017
    Date of Event
    March 28, 1996
    Report Date
    May 3, 2017
    Manufacturer
    BRIGGS MEDICAL
    Product Code
    FPY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE IS NO EXPIRATION DATE OR SHELF LIFE DATA ON THE PACKAGING FOR THIS PRODUCT. STERILE BURN SHEET 60" X 96" CRUMBLED WHEN WE REMOVED AND APPLIED IT TO THE PT. BLUE DUST WAS IN THE WOUNDS. PT WAS A TRAUMA CODE WITH EXTENSIVE BURNS. BURN CART WAS PULLED INTO THE ROOM TO USE THE SUPPLIES IN THE CART. THE STERILE BURN SHEET WAS REMOVED FROM THE CART AND REMOVED FROM ITS SEALED PACKAGE. UPON PUTTING IT ON THE PT THE SHEET DISINTEGRATED ON TOP OF THE PT. IT WAS IMMEDIATELY REMOVED BY STAFF BUT SMALL BLUE FIBERS FROM THE SHEET WERE LEFT ON THE PT'S BODY IN BURNED AREAS. PT WAS ESTIMATED TO HAVE 70% BURNS ON HIS BODY. THERE IS NO EXPIRATION DATE OR MENTION OF SHELF LIFE ON THE PACKAGING. THERE IS A LOT NUMBER. AFTER RESEARCH THERE WAS A SAFETY NOTICE SENT IN 1997 REFERENCING PRODUCT ISSUES AFTER 3 YEARS FROM THE MANUFACTURE DATE. THE MANUFACTURE DATE IS PART OF THE LOT NUMBER. ALSO LEARNED FROM RESEARCH OF PRODUCT. ALL THE BURN SHEETS WERE FROM 2013 AND 2012. DIAGNOSIS OR REASON FOR USE: BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349205 DURO-MED GAM STERILE BURN BLANKET BURN BLANKET FPY BRIGGS MEDICAL 60" X 90" JT12513

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention