BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCHOICE HIGH SPEED DRILL

    MDR report key: 336725 · Received June 5, 2001

    Report

    Report Number
    1017294-2001-00055
    Event Type
    Malfunction
    Date Received
    June 5, 2001
    Date of Event
    May 11, 2001
    Report Date
    May 14, 2001
    Manufacturer
    LINVATEC CORP.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE DEVICE BECAME HOT TO THE TOUCH DURING PRE-OPERATIVE TESTING. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25793 MICROCHOICE HIGH SPEED DRILL HIGH SPEED DRILL HTW LINVATEC CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN