BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPEX

    MDR report key: 2469204 · Received February 10, 2012

    Report

    Report Number
    8031010-2012-00003
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Report Date
    January 13, 2012
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    LQY
    PMA / PMN Number
    K992233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION MAY HAVE CAUSED THE SENSATION, OR IT MAY HAVE BEEN THE RESULT OF STATIC ELECTRICITY OR OTHER FACTORS. THE PROPEX UNIT DOES NOT FUNCTION WHEN PLUGGED IN; RATHER THE UNIT OPERATES ON A 2.4V BATTERY WHEN USED WITH A PT. THOUGH THERE WAS NO REPORT OF INJURY, BECAUSE DEVICE EVAL RESULTS ARE NOT AVAILABLE AS OF THIS MDR EVAL, THIS INCIDENT WOULD BE CONSIDERED A MALFUNCTION WHICH, IF IT WERE TO RECUR, COULD POSSIBLY RESULT IN PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR FUNCTION OF RESULT IN AN INJURY REQUIRING MEDICAL INTERVENTION TO PRECLUDE SUCH, PARTICULARLY IF THE DEVICE WAS USE WITH A PT IMPLANTED WITH A PACEMAKER, AS CONTRAINDICATED IN THE DFU. THEREFORE, THIS EVENT IS REPORTABLE PER 21 CFR 803. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT TWO PTS EXPERIENCED AN ELECTRICAL SHOCKING SENSATION DURING USE OF A PROPEX II APEX LOCATOR; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPEX LQY DENTSPLY MAILLEFER 1041555

    Patients

    Seq Age Sex Outcome Treatment
    1