BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIATURE PIN & LIGATURE CUTTER

    MDR report key: 1689292 · Received May 5, 2010

    Report

    Report Number
    2086211-2010-00060
    Event Type
    Malfunction
    Date Received
    May 5, 2010
    Report Date
    March 24, 2010
    Manufacturer
    GAC INTERNATIONAL
    Product Code
    EJB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 EVAL, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A MINIATURE PIN AND LIGATURE CUTTER SEPARATED OUTSIDE OF A PT'S MOUTH; THERE IS NO INDICATION THAT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIATURE PIN & LIGATURE CUTTER EJB GAC INTERNATIONAL 06-49-2

    Patients

    Seq Age Sex Outcome Treatment
    1