BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER INSTRUMENTS

    MDR report key: 1432375 · Received August 5, 2009

    Report

    Report Number
    MW5012265
    Event Type
    Injury
    Date Received
    August 5, 2009
    Date of Event
    May 8, 2009
    Report Date
    July 23, 2009
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    DZI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE PHYSICIAN NOTICED THAT THE HANDLE OF THE TPS WAS HOT. THE PT RECEIVED A BURN TO THE LIP MUCOSA AND SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER INSTRUMENTS MICRO DRILL DZI STRYKER INSTRUMENTS 5100-15 (TPS CORD)-07171
    2 STRYKER INSTRUMENTS DRILL ATTACHMENT HTW STRYKER INSTRUMENTS 5100-15-250
    3 STRYKER INSTRUMENTS TPS CORD HTW STRYKER INSTRUMENTS 5100-4

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other