BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA MOTUS AX AY LASER HAIR REMOVAL

    MDR report key: 11163432 · Received January 12, 2021

    Report

    Report Number
    MW5098798
    Event Type
    Injury
    Date Received
    January 12, 2021
    Date of Event
    January 4, 2021
    Report Date
    January 11, 2021
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD USED THE YAG SERIES FOR A YEAR AND NEEDED A FEW TOUCH UPS. THIS PRACTICE RECOMMENDED THE MOTUS AX MACHINE FOR THREE SESSIONS. DURING THE TREATMENT, I EXPERIENCED THE MOST PAIN I HAVE EVER HAD DURING A LASER TREATMENT. IT LITERALLY FELT MY SKIN WAS ON FIRE. LITTLE DID I KNOW, IT WAS. I COULD NOT SIT DOWN OR PUT MY HAND DOWN FOR 2 HOURS AFTER THE PROCEDURE. I FOLLOWED THE DOCTOR'S INSTRUCTIONS TO APPLY ALOE VERA, BUT THINGS ONLY GOT WORSE. THE FOLLOWING DAY, I HAD MASSIVE, RAISED BLACK WELTS ALL OVER MY BODY. I CALLED THE OFFICE AND WAS TOLD TO CONTINUE WITH ALOE VERA THAT THEY HAVE NEVER EXPERIENCED THIS TYPE OF SCENARIO. THEY ALSO MENTIONED MAYBE MY SKIN WAS SENSITIVE AND THAT MY DARKER SKIN MAY NOT BE A GOOD CANDIDATE FOR MOTUS AX AFTER ALL. OF COURSE, THIS IS AFTER I WAS ENCOURAGED TO USE THE PRODUCT BECAUSE OF ITS NUANCED TECHNOLOGY OF BEING WELL VERSED FOR ALL SKIN TYPES AND COLORS. WELTS DEVELOPED INTO A SEVERE AND PAINFUL SIGHT OF DARK AND SOME OPEN BRUISES ALL AROUND AND OVER MY BIKINI, PERINATAL, AND UNDERARM AREA. NOT ONLY IS IT UNSIGHTLY AND QUITE TRAUMATIC TO SEE, IT IS PAINFUL. I COULDN'T BE AROUND MY HUSBAND IN ANYWAY SHAPE OR FORM BECAUSE OF THE VISUAL EFFECT OF THE BURNS AND THE PHYSICAL PAIN. THIS HAS CAUSED INTENSE EMOTIONAL DISTRESS FOR ME AND HAS IMPACTED MY QUALITY OF LIFE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54611 DEKA MOTUS AX AY LASER HAIR REMOVAL POWERED LASER SURGICAL INSTRUMENT GEX EL.EN. ELECTRONIC ENGINEERING SPA

    Patients

    Seq Age Sex Outcome Treatment
    1