BEUDAMED
    FDA Adverse Event Other Summary report: N

    TPS STRYKER HANDPIECE MICRO DRILL

    MDR report key: 2114599 · Received June 1, 2011

    Report

    Report Number
    MW5020859
    Event Type
    Other
    Date Received
    June 1, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 24, 2011
    Manufacturer
    STRYKER
    Product Code
    DZI
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TPS HANDPIECE BECAME HEATED WHILE BEING USED IN SURGERY WHICH RESULTED IN A FIRST DEGREE BURN TO RIGHT SIDE OF FACE JUST BELOW LIP. THE HANDPIECE WAS TAKEN OUT OF SERVICE AND A NEW TPS HANDPIECE WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPS STRYKER HANDPIECE MICRO DRILL DZI STRYKER

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR