BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA PADGETT DERMATOME

    MDR report key: 2993169 · Received February 26, 2013

    Report

    Report Number
    MW5029201
    Event Type
    Injury
    Date Received
    February 26, 2013
    Date of Event
    February 14, 2012
    Report Date
    February 26, 2013
    Manufacturer
    INTEGRA LIFE SCIENCES CORP
    Product Code
    GFD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTEGRA PADGETT DERMATOME "MALFUNCTIONED" AND WITH THICKNESS SET AND IN THE PROCESS OF OBTAINING GRAFTS FROM THE LEFT ANTEROLATERAL THIGH, THE GRAFT WAS NOTED TO BE QUITE THICK AND SUBCUTANEOUS FAT COULD BE SEEN FROM THE HARVEST SITE. THE DONOR SITE WAS TERMINATED AND THE DONOR SKIN WAS THEN PLACED BACK INTO THE HARVEST SITE AND SUTURED INTO PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81630 INTEGRA PADGETT DERMATOME PADGETT DERMATOME GFD INTEGRA LIFE SCIENCES CORP 15

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization