BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME

    MDR report key: 3181377 · Received June 14, 2013

    Report

    Report Number
    3004608878-2013-00113
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE NEEDED RECALIBRATION. THERE WAS PATIENT CONTACT BUT NO INJURY/DEATH ALLEGED. ADDITIONAL INFORMATION WAS REQUESTED AND ON 06/10/2013, THE FOLLOWING WAS RECEIVED FROM THE RN/SURGERY CLINICAL COORDINATOR: A (B)(6) MALE PATIENT UNDERWENT A DEBRIDEMENT WITH SPLIT THICKNESS SKIN GRAFT (STSG) BILATERAL LEGS. THE REASON THE DERMATOME NEEDED TO BE RECALIBRATED WAS BECAUSE ON THE FIRST ATTEMPT AT HARVESTING THE SKIN, THE DERMATOME SKIPPED/BOUNCED ACROSS THE SKIN A COUPLE TIMES. THE SKIN HARVESTED HAD HOLES IN, IT WAS MISSHAPEN, AND WAS TOO NARROW. THE SURGEON REPOSITIONED THE DERMATOME AND ATTEMPTED AT ANOTHER SITE WITH THE SAME RESULT. THE SURGEON REQUESTED ANOTHER DERMATOME. IT TOOK APPROXIMATELY THREE MINUTES FOR ANOTHER DERMATOME TO BE BROUGHT TO THE ROOM, OPENED ONTO THE FIELD, AND HOOKED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270659 PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME SKIN GRAFT PRODUCTS GFD INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention