BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER

    MDR report key: 3190337 · Received June 18, 2013

    Report

    Report Number
    3190337
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    WHEN SKIN GRAFT WAS TAKEN, THE DERMATOME DID NOT OPERATE SMOOTHLY WITH RESULT OF IRREGULAR SKIN GRAFT. A NEW DERMATOME AND BLADE WERE USED TO TAKE ANOTHER SKIN GRAFT FROM SAME THIGH ONLY LOWER SITE. PATIENT WAS DISCHARGED SAME DAY AND PER SURGEON, SITE IS HEALING WELL WITHOUT SCAR.======================MANUFACTURER RESPONSE FOR ZIMMER AIR DERMATOME SET, ZIMMER DERMATOME (PER SITE REPORTER).======================NO RESPONSE AS OF THIS DATE 6/18/2013.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ON (B)(6) 2013, PATIENT WITH MALIGNANT MELANOMA OF LEFT HEEL WAS TO UNDERGO LEFT SARTORIUS MUSCLE FLAP, SPLIT THICKNESS SKIN GRAFT TO LEFT HEEL FROM RIGHT ANTERIOR THIGH.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277195 ZIMMER DERMATOME GFD ZIMMER SURGICAL 00-88-1001-00 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR