BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICRO 100 DRILL

    MDR report key: 682678 · Received March 3, 2006

    Report

    Report Number
    1017294-2005-00285
    Event Type
    Other
    Date Received
    March 3, 2006
    Date of Event
    March 31, 2004
    Report Date
    November 4, 2005
    Manufacturer
    LINVATEC CORPORATION
    Product Code
    DZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORAL SURGICAL PROCEDURE (WISDOM TOOTH EXTRACTION) THAT THE DRILL GOT HOT. THE PT RECEIVED A BURN TO THE RIGHT UPPER LIP EXTENDING TOT HE CORNER OF THE LIP AND ON THE BOTTOM OF THE LIP. SURGEON ORDERED A PLASTIC SURGEON CONSULT. NO OTHER INFO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO 100 DRILL DRILL DZI LINVATEC CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other