BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME

    MDR report key: 3193558 · Received June 25, 2013

    Report

    Report Number
    3004608878-2013-00122
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 25, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    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 UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT DID NOT CUT THE GRAFT CORRECTLY ("MANGLED GRAFT"). ADDITIONAL INFORMATION WAS REQUESTED AND ON (B)(4) 2013, THE FOLLOWING WAS PROVIDED BY THE CUSTOMER: DURING A SPLIT THICKNESS SKIN GRAFT TO AN ABDOMINAL WOUND CLOSURE ON A (B)(6) FEMALE PT, THE DERMATOME SKIPPED ALONG THE SURFACE OF THE SKIN, RATHER THAN GLIDING AS USUAL. THIS RENDERED THE GRAFT UNUSABLE SINCE IT WAS ONLY CLUMPS AND PIECES. UPON OPENING A SECOND DERMATOME, AND RE-PREPPING AND RE-DRAPING FOR A THIRD DONOR SITE, THE GRAFT WAS TAKEN WITHOUT INCIDENT (A SECOND AND THIRD DONOR SITE WAS NECESSARY TO COMPLETE THE PROCEDURE). THERE WAS A 15 MINUTED DELAY IN SURGERY DUE TO HAVING TO RE-PREP, RE-DRAPE FOR ANOTHER DONOR SITE. PT OUTCOME WAS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288933 PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME SKIN GRAFT PRODUCTS GFD INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention