BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGITOME E HANDPIECE

    MDR report key: 425731 · Received October 31, 2002

    Report

    Report Number
    1017294-2002-00087
    Event Type
    Other
    Date Received
    October 31, 2002
    Date of Event
    October 11, 2002
    Report Date
    October 11, 2002
    Manufacturer
    LINVATEC CORP.
    Product Code
    DZI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT IS ALLEGED THE DEVICE BECAME HOT WHILE IN USE. THE PT RECEIVED A BURN ON THE LOWER LIP, NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITOME E HANDPIECE DRILL DZI LINVATEC CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN