BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRIC DERMATOME KIT

    MDR report key: 1920105 · Received December 8, 2010

    Report

    Report Number
    1526350-2010-00183
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER ELECTRIC DERMATOME WAS NOT CUTTING THE SKIN PROPERLY. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL ON (B)(6), 2010 INDICATED THE UNIT WAS TAKING A CHUNK OF TISSUE AT THE RIGHT CORNER AND HAD TO BE REPAIRED USING SUTURES.

    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 Required Intervention