BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADGETT ELECTRO-DERMATOME MODEL B 110 V

    MDR report key: 978643 · Received January 19, 2006

    Report

    Report Number
    978643
    Event Type
    Malfunction
    Date Received
    January 19, 2006
    Report Date
    January 19, 2006
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A COPY OF THE USER FACILITY VOLUNTARY MEDWATCH WAS REC'D. THE FOLLOWING INCIDENT WAS REPORTED ON THE MEDWATCH: ENT PHYSICIAN TOOK SKIN GRAFT FROM ANESTHETIZED PT. THE GRAFT WAS NOT USABLE. THE SURGEON REPORTED THE EQUIPMENT WAS PITTED AND CANCELLED THE PROCEDURE. THE PT'S SKIN GRAFT SITE WAS OKAY. IT WAS FURTHER REPORTED THAT THE PLASTIC SURGEONS WHO USE THIS EQUIPMENT OIL THE SKIN AND HOLD TAUT WHEN TAKING A GRAFT. THE ENT PHYSICIAN DID NOT UTILIZE THIS TECHNIQUE. THE UNIT INVOLVED IN THE REPORTED INCIDENT WAS MANUFACTURED ON 02/24/1989 AND LAST SERVICED ON 02/23/1995. CONTACT HAS BEEN MADE WITH THE USER FACILITY, HOWEVER, TO DATE, THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PADGETT ELECTRO-DERMATOME MODEL B 110 V PADGETT ELECTRIC DERMATOME GFD INTEGRA LIFESCIENCES CORPORATION 3539-250 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *