BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPEX

    MDR report key: 2132400 · Received June 13, 2011

    Report

    Report Number
    8031010-2011-00081
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Report Date
    May 23, 2011
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    PMA / PMN Number
    K992233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THERE IS APPARENTLY NO REPORT OF INJURY IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITHIN THE PAST TWO YEARS INVOLVING THIS MALFUNCTION THAT RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THIS EVENT WILL BE REEVALUATED, AS APPROPRIATE, IF FURTHER INFORMATION BECOMES AVAILABLE. THE DEVICE WAS EVALUATED AND FOUND TO HAVE A PCB AND BATTERY MALFUNCTION AND THE FRONT PANEL BROKEN.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PROPEX APEX LOCATOR PROVIDED INCORRECT MEASUREMENTS; OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR EVALUATION. HOWEVER, THERE IS NO INDICATION THAT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPEX LQY DENTSPLY MAILLEFER 0401919

    Patients

    Seq Age Sex Outcome Treatment
    1