BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALL SURGICAL BUR GUARD

    MDR report key: 395195 · Received May 13, 2002

    Report

    Report Number
    1017294-2002-00041
    Event Type
    Malfunction
    Date Received
    May 13, 2002
    Date of Event
    April 26, 2002
    Report Date
    May 3, 2002
    Manufacturer
    LINVATEC CORP.
    Product Code
    GET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    USER FACILITY STATES THAT THE DEVICE BECAME HOT DURING USE. NO REPORT OF INJURY TO USER OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALL SURGICAL BUR GUARD BUR GUARD GET LINVATEC CORP. NA JAN93S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA