BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPEX

    MDR report key: 1873690 · Received October 13, 2010

    Report

    Report Number
    8031010-2010-00131
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Report Date
    September 17, 2010
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    PMA / PMN Number
    P992233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    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 WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS RETURNED AND EVALUATED. THE EVALUATION FOUND THAT THE BATTERY WOULD NOT CHARGE AND THE HOOK AND MEASURING WIRE DID NOT HAVE CORRECT ELECTRICAL CONTACT. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PROPEX II APEX LOCATOR PROVIDED INCORRECT MEASUREMENTS; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPEX LQY DENTSPLY MAILLEFER 0742735

    Patients

    Seq Age Sex Outcome Treatment
    1