BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACTION BUR GUARD

    MDR report key: 829837 · Received March 16, 2007

    Report

    Report Number
    1811755-2007-00013
    Event Type
    Injury
    Date Received
    March 16, 2007
    Date of Event
    March 6, 2007
    Report Date
    March 7, 2007
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    EEJ
    PMA / PMN Number
    K961970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    PT RECEIVED A BURN ON THE UPPER LIP FACIAL AREA DURING SURGERY. PRESCRIPTIONS FOR PAIN, ANTIBIOTICS, AND ANTIVIRAL WERE ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACTION BUR GUARD GUARD, DISK EEJ STRYKER INSTRUMENTS KALAMAZOO * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention