BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACTION DRILL

    MDR report key: 1180047 · Received September 24, 2008

    Report

    Report Number
    1811755-2008-00061
    Event Type
    Injury
    Date Received
    September 24, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 2008
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HAND PIECE HAS BEEN RECEIVED AT THE MANUFACTURER, THE INVESTIGATION HAS NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORAL PROCEDURE, THE PATIENT RECEIVED A BURN TO THE LIP. THERE WAS NO ADDITIONAL TREATMENT REPORTED AS A RESULT OF THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACTION DRILL BONE CUTTING INSTRUMENT AND ACCESSORIES DZJ STRYKER INSTRUMENTS KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention