BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRAC VELOCITY AL 10000

    MDR report key: 4921938 · Received July 1, 2015

    Report

    Report Number
    2031934-2015-00002
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    March 2, 2015
    Report Date
    June 19, 2015
    Manufacturer
    PHOTO MEDEX, INC.
    Product Code
    GEX
    PMA / PMN Number
    K073695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THROUGH EVALUATION THAT THE DEVICE WAS OPERATING IN ACCORDANCE WITH SPECIFICATIONS AND , NO UNINTENDED OPERATION WAS CONFIRMED OR REPLICATED DURING THE EVALUATION. NO CAUSE WAS FOUND THAT MAY HAVE CAUSED OR MAY HAVE CONTRIBUTED OT CAUSE THE ALLEGED EVENT AT THE DR'S OFFICE. LATER ON (B)(6) 2015, WAS CONFIRMED THAT AFTER REPLACEMENT OF THE CONTROL SWITCH AT THE DOCTORS OFFICE, NO FURTHER INCIDENTS HAVE OCCURRED. UPON INITIAL REVIEW OF THE COMPLAINT, IT DID NOT APPEAR TO BE A REPORTABLE INCIDENT, AFTER FURTHER REVIEW AND DISCUSSION, IT WAS DETERMINE NECESSARY TO REPORT THIS INCIDENT DUE TO THE EVENT DETAILS SUGGEST THAT THE DEVICE MAY HAVE CONTRIBUTED TO A SERIOUS INJURY, IF THE MALFUNCTION WERE TO OCCUR, THIS EXPLAINS THE TIME LAG IN REPORTING. THOUGH, THE LIKELIHOOD IS IMPROBABLE AND THE SAFETY FEATURES WILL CONTRIBUTE TO PRECLUDE A SERIOUS INJURY.

    Description of Event or Problem · 1

    ON (B)(6) 2015, IT WAS REPORTED TO PHOTOMEDEX BY (B)(6), THAT THE DEVICE USER WAS HAVING ISSUES WITH THE CONTROL SWITCH OF THE DEVICE, WHICH WAS NOT WORKING AS EXPECTED-OPERATING UNINTENDEDLY. PHOTOMEDEX SERVICE MANAGER SPOKE WITH THE (B)(6) 2015 AND, DETERMINED THAT A NEW CONTROL SWITCH WOULD HAVE TO BE SHIPPED OUT TO REPLACE THE CONTROL SWITCH PRESENTING ISSUES. LATER ATTEMPT WAS MADE ON (B)(6) 2015, BY PHOTOMEDEX (B)(4) TO GATHER FURTHER DETAILS, WITH THE DEVICE USER TO CONFIRM UNINTENDED OPERATION OF THE CONTROL SWITCH OR INTERMITTENT OPERATION OF THE CONTROL SWITCH, HOWEVER, THE DEVICE USER NO LONGER WORKS AT THE SITE. AS OF (B)(6) 2015, HAS BEEN DETERMINED TO BE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429511 XTRAC VELOCITY AL 10000 GEX PHOTO MEDEX, INC. V7

    Patients

    Seq Age Sex Outcome Treatment
    1