BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRACLEAR PULSED LIGHT SYSTEM - SPATOUCH PRO

    MDR report key: 1063409 · Received June 20, 2008

    Report

    Report Number
    MW5007370
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    December 11, 2007
    Report Date
    June 9, 2008
    Manufacturer
    RADIANCY, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CLASS II, INTENSE PULSED LIGHT HAIR REMOVAL DEVICE, MARKETED AS THE SPECTRACLEAR SYSTEM WAS DISTRIBUTED TO A CHIROPRACTOR IN 2004. THE DEVICE WAS MANUFACTURED BY RADIANCY, INC., UNDER THE NAME SPATOUCH PRO. DISTRIBUTOR, IN 2005, RECEIVED WRITTEN NOTICE FROM THE STATE THAT IT PROHIBITS CHIROPRACTORS FROM USING THEIR MEDICAL DEVICE. THEY ONLY PERMIT PHYSICIANS LICENSED BY THE BOARD OF MEDICAL EXAMINERS TO PERFORM HAIR REMOVAL WITH LASER OR PULSED LIGHT DEVICES, AND THESE PROCEDURES CANNOT BE DELEGATED TO NON-PHYSICIANS. DISTRIBUTOR KNEW OF SIMILAR RESTRICTIONS IN OTHER STATES. IN 2007, THE CHIROPRACTOR USED THE DEVICE TO PERFORM HAIR REMOVAL, CAUSING 2ND DEGREE BURNS ON THE PT'S FACE AND ARMS. THE CHIROPRACTOR DID NOT COMPLY WITH PT EXCLUSION CRITERIA LISTED IN THE SPECTRACLEAR OPERATOR MANUAL WHICH STATES THAT PTS WHO HAVE BEEN TANNING WITHIN THE PAST 30 DAYS SHOULD NOT BE TREATED. THIS PT HAD DISCLOSED THAT SHE HAD BEEN TANNING THREE TIMES IN THE WEEK BEFORE HER HAIR REMOVAL TREATMENT. THE COMPLAINT SETS FORTH ALLEGATIONS DEMONSTRATING THAT DISTRIBUTOR MARKETED HAIR REMOVAL DEVICES TO CHIROPRACTORS IN MANY STATES, AND RECEIVED WRITTEN NOTICE FROM SEVERAL STATE CHIROPRACTIC BOARDS THAT CHIROPRACTORS WERE NOT PERMITTED TO USE INTENSE PULSED LIGHT (IPL) DEVICES FOR HAIR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRACLEAR PULSED LIGHT SYSTEM - SPATOUCH PRO HAIR REMOVAL DEVICE GEX RADIANCY, INC. SPATOUCH PRO

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| R| S