BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACTION BUR GUARD

    MDR report key: 70726 · Received February 18, 1997

    Report

    Report Number
    1811755-1997-00016
    Event Type
    Injury
    Date Received
    February 18, 1997
    Date of Event
    January 2, 1997
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    EEJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    BUR GUARD SLID UP IN DRILL AND BURNED THAT PT WITH 3RD DEGREE BURNS. BURN WAS TREATED WITH AN ANTIBIOTIC CREAM AND REFERRED TO PLASTIC SURGEON. THERE WILL BE RESIDUAL SCARRING ON THE RIGHT LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACTION BUR GUARD BUR GUARD EEJ STRYKER INSTRUMENTS 2296-301-000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention