BEUDAMED
    FDA Adverse Event Summary report: N

    TIME MACHINE/ELECTRICAL STIMULATOR

    MDR report key: 11366 · Received February 1, 1994

    Report

    Report Number
    MW4000134
    Date Received
    February 1, 1994
    Report Date
    July 11, 1993
    Manufacturer
    CONNIE STEVENS FOREVER SPRING BEAUTY SYSTEM
    Product Code
    IRO
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SVC IS PROMOTED VIA TELEVISION. THE COMPLAINANT ALLEGES THAT AFTER USING THE SYSTEM 7 OR 8 TIMES, SHE BEGAN HAVING HAIR GROWTH ON HER FACE, WHEREEVER THE DEVICE WAS APPLIED. DEVICE IS AN ELECTRICAL STIMULATOR USED IN CONJUNCTION WITH A COLLAGEN QUENCHER. INSTRUCTIONS TELL YOU WHERE TO PLACE THE DEVICE ON YOUR FACE FOR A MINUTE AT A TIME CAUSING YOU TO FEEL A PULSING ELECTRICAL STIMULATION. THERE ARE APPROX 14 POINTS ON THE FACE. THE COMPLAINANT SAW HER DR WHO AT FIRST THOUGH IT WAS AN ALLERGIC REACTION. TESTS SHOWED NO ALLERGIC REACTION. A CHECK FOR HORMONAL IMBALANCE WAS NEGATIVE. COMPLAINANT SAID AFTER USING THE MACHINE SHE ALSO HAD TREMENDOUS PRESSURE ON HER FOREHEAD AND SHE FELT A BURNING OF THE MOUTH AND BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIME MACHINE/ELECTRICAL STIMULATOR IRO CONNIE STEVENS FOREVER SPRING BEAUTY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 *