BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-MINIATURE LIGHT WIRE CUTTER

    MDR report key: 1901150 · Received November 10, 2010

    Report

    Report Number
    2086211-2010-00122
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Report Date
    October 13, 2010
    Manufacturer
    GAC INTERNATIONAL
    Product Code
    EJB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED IN THE PAST TWO YEARS INVOLVING A SIMILAR DEVICE WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT THE TIP OF A MICRO-MINIATURE LIGHT WIRE CUTTER SEPARATED; THERE IS NO INDICATION THAT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-MINIATURE LIGHT WIRE CUTTER EJB GAC INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1