BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPA TOUCH

    MDR report key: 520125 · Received March 25, 2004

    Report

    Report Number
    MW1031677
    Event Type
    Malfunction
    Date Received
    March 25, 2004
    Date of Event
    February 22, 2003
    Report Date
    March 25, 2004
    Manufacturer
    RADIANCY, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDICAL DEVICE MARKETED BY RADIANCY, INC BY REP AS CURE OR "ERADICATION" OF ACNE. THIS WAS STATED EMPHATICALLY ON MORE THAN ONE OCCASION TO PT'S MEDICAL PROVIDER. AFTER HOURS MEDICAL CLINIC WAS THE SOLE REASON FOR PT PURCHASING SERVICES. RADIANCY'S L.H.E. -LIGHT HEAT ENERGY-, WHICH IS TO THEIR UNDERSTANDING UP FOR APPROVAL BY THE F.D.A., WAS TOUTED THAT IT WOULD "ERADICATE ACNE". THIS TREATMENT ONLY PROVIDED MARGINAL IMPROVEMENT FOR PT AT FIRST REGARDING CHRONIC ACNE THAT PT EXPERIENCES ON THEIR BACK. HOWEVER, AFTER SEVERAL TREATMENTS THEIR ACNE RETURNED TO THE STATE WHERE IT WAS WHEN PT BEGAN THIS PROCESS, IF IT WASN'T EVEN WORSE. THE TREATMENTS WERE CARRIED OUT TO SPECIFICATION, AS CONTACT WAS MAINTAINED & DEVICE TAKEN FROM THE CO REP FROM ATLANTA THROUGH MOST OF THE DURATION OF THESE TREATMENTS. PT WOULD LIKE THEIR $800.00 BACK FROM RADIANCY, INC., WHICH WAS THE FEE PRE-NEGOTIANTED WITH PT'S MEDICAL PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPA TOUCH LIGHT HEAT ENERGY GEX RADIANCY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other