BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PADGETT MODEL S LIMLINE ELECTRIC DERMATOME

    MDR report key: 3011015 · Received March 11, 2013

    Report

    Report Number
    3004608878-2013-00041
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    January 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION (INTEGRA-OHIO)
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    RECEIVED VIA (B)(4). "PADGETT DERMATOME 320 MALFUNCTIONING DURING THE CASE WHILE HARVESTING; THE GUARD LOOSENED UP AND TOOK A FULL THICKNESS SKIN GRAFT FROM PT'S RIGHT THIGH. IT WAS TIGHTENED AND CHECKED BY PHYSICIAN AND PHYSICIAN'S ASSISTANT PRIOR TO USE. IT WAS THEN TAKEN OUT OF OPERATION, AND A NEW DERMATOME WAS OBTAINED. USE OF PRODUCT DURING SURGERY ON 2013 WHEN IT MALFUNCTIONED. DATES OF USE: 2013." ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102488 PADGETT MODEL S LIMLINE ELECTRIC DERMATOME SKIN GRAFT PRODUCTS GFD INTEGRA LIFESCIENCES CORPORATION (INTEGRA-OHIO)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention