BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROCHOICE MEDIUM BUR GUARD

    MDR report key: 876922 · Received March 12, 2007

    Report

    Report Number
    1017294-2007-00147
    Event Type
    Other
    Date Received
    March 12, 2007
    Report Date
    February 15, 2007
    Manufacturer
    CONMED LINVATEC
    Product Code
    DZI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE BUR GUARD WAS RECEIVED FOR EVALUATION AND DURING TESTING, IT DID NOT GET HOT; IT OPERATED WITHIN TEMPERATURE SPECIFICATION. FURTHER INVESTIGATION FOUND NO FAULTS WITH THIS DEVICE. THE CUSTOMER WILL BE CONTACTED TO PROVIDE SERVICING INFORMATION FOR THIS PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THIS BUR GUARD WITH DRILL, THE PATIENT'S LOWER LIP GOT BURNT. ANTIBIOTIC OINTMENT WAS APPLIED TO THE AREA AND THE PATIENT WAS DISCHARGED HOME. TO DATE, NO FURTHER TREATMENT IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROCHOICE MEDIUM BUR GUARD BUR GUARD DZI CONMED LINVATEC NA NOV06S

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other CATALOG#: 00502002500| MICROCHOICE HIGH SPEED DRILL