BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPILIGHT

    MDR report key: 252213 · Received December 1, 1999

    Report

    Report Number
    MW1017659
    Event Type
    Other
    Date Received
    December 1, 1999
    Date of Event
    October 1, 1998
    Report Date
    November 30, 1999
    Manufacturer
    ESC MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR OBTAINED AN EPILIGHT FROM THE ESC CO OVER A YEAR AGO FOR PERMANENT HAIR REDUCTION. DR HAS TREATED MANY PTS WITH THIS AND HAS BEEN DISMAYED TO SEE THE COMPLETE LACK OF RESULTS. HAIR REGROWTH AFTER 3 MOS IS QUITE DRAMATIC FOR MOST PTS. INTERESTINGLY, THE "STANDARD CONTRACT" GIVEN BY THE CO DISAVOWS ANY RESPONSIBILITY FOR THE MACHINE TO OPERATE AND PERFORM FOR ITS STATED PURPOSE. DR HAS HAD TO REFUND MONEY TO MOST OF HIS PTS. THE CO HAS BEEN VERY DIFFICULT TO DEAL WITH BECAUSE "I OBTAINED IT UNDER A LEASE/PURCHASE AGREEMENT. THEY SAY THAT THEY HAVE NO OBLIGATION TO ME OR TO MY PTS BECAUSE THE MACHINE IS TECHNICALLY OWNED BY THE LEASING CO (WITH WHOM THEY HAVE A 'SPECIAL' RELATIONSHIP). I UNDERSTAND THE FDA HAS APPROVED THE DEVICE FOR 'PERMANENT HAIR REDUCTION', BUT THE FDA DIDN'T TEST MY MACHINE." DR HAS REPLACED EVERY PIECE ON THIS MACHINE, AND IT STILL DOESN'T WORK. DR HAD A FLASH BURN ON A PT AND STOPPED USING IT COMPLETELY. ALTHOUGH DR HAS FOUND THE MACHINE TO BE UNRELIABLE, INEFFECTIVE AND IN ONE INSTANCE HAZARDOUS, THE CO REFUSES TO TAKE THE MACHINE BACK BECAUSE "I'M NOT THE OWNER. ON THE OTHER HAND, I MUST KEEP PAYING FOR IT. I WOULD WELCOME RE-REVIEW BY YOUR REGULATORY AGENCY REGARDING THE EFFECTIVENESS OF THE EPILIGHT SYSTEM OF EPILATION. I WOULD WELCOME YOUR EVALUATION OF MY MACHINE IN PARTICULAR. EVEN OUR SALESWOMAN SAID IT WAS NOT WORKING PROPERLY. THE MACHINE TAKES A LONG TIME TO RECYCLE BETWEEN FLASHES. EVERY WORKING PART OF THE MACHINE HAS BEEN REPLACED AT LEAST ONCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPILIGHT PHOTOEPILATION DEVICE GEX ESC MEDICAL SYSTEMS, INC. SA4201003 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other