BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIODESIGN SURGISIS 8-LAYER TISSUE GRAFT

    MDR report key: 2522748 · Received June 25, 2010

    Report

    Report Number
    1835959-2010-00005
    Event Type
    Other
    Date Received
    June 25, 2010
    Date of Event
    May 13, 2010
    Report Date
    June 25, 2010
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    FTL
    PMA / PMN Number
    K062697
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS STERILIZED VIA A VALIDATED STERILIZATION CYCLE THAT HAS AN STERILITY ASSURANCE LIMIT (SAL) OF 10 TO THE -6 POWER. THE STERILIZATION CYCLE ASSOCIATED WITH THIS DEVICE WAS REVIEWED AND IT MET ALL OF THE PARAMETERS FOR ACCEPTANCE. THE FOLLOWING LANGUAGE WAS TAKEN DIRECTLY FROM THE INSTRUCTIONS FOR USE (IFU): "THIS GRAFT HAS BEEN REPORTED TO BE SAFE IN CLEAN AND CLEAN-CONTAMINATED HERNIA REPAIR. HOWEVER, CARE SHOULD BE EXERCISED WHEN IT IS PLACED IN CRITICALLY ILL PATIENTS OR SEVERELY CONTAMINATED WOUNDS."

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH AN INFECTED MESH FROM A PREVIOUS SURGERY. THE SURGEON REMOVED THE OLD MESH AND REPLACED WITH THE BIODESIGN SURGISIS 8 LAYER TISSUE GRAFT. FOUR DAYS POST IMPLANTATION THE SURGEON NOTED THAT THE WOUND SITE APPEARED INFECTED. UPON REOPERATION, SURGEON NOTED THE GRAFT HAD DISSOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIODESIGN SURGISIS 8-LAYER TISSUE GRAFT SURGICAL MESH 21CFR878.3300 FTL COOK BIOTECH, INC. G29683 LB452611

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention NONE KNOWN