BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRIC DERMATOME KIT

    MDR report key: 1980227 · Received February 1, 2011

    Report

    Report Number
    1526350-2011-00020
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 13, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. THE SERVICE RECORDS INDICATE THE DEVICE IS 2 YEARS OLD. THE LAST REPAIR WAS ON (B)(6) 2010, FOR A NON RELATED ISSUE. A VISUAL INSPECTION FOUND THE DEVICE MET ALL PERFORMANCE SPECIFICATIONS. THE INVESTIGATION WAS UNABLE TO DETERMINE THE CAUSE OF REPORTED ISSUE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER ELECTRIC DERMATOME WAS NOT CUTTING, SKIPPING. ADDITIONAL INFO RECEIVED THROUGH CLINICAL FOLLOW UP WITH THE HOSPITAL ON (B)(6) 2011, INDICATED THAT THE DEVICE WAS "TEARING CHUCKS OUT, COMING OFF IN PIECES WHICH WERE INCONSISTENT IN THICKNESS, AND RAGGED." ADDITIONAL TISSUE HARVESTING WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRIC DERMATOME KIT ELECTRIC DERMATOME KIT GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1