BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT BASED OVER-THE-COUNTER HAIR REMOVAL

    MDR report key: 9910194 · Received March 31, 2020

    Report

    Report Number
    MW5093994
    Event Type
    Injury
    Date Received
    March 31, 2020
    Date of Event
    March 28, 2020
    Report Date
    March 28, 2020
    Manufacturer
    CYDEN LIMITED
    Product Code
    OHT
    UDI-DI
    6905588240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SKIN ALLERGY REACTION; I USED FDA CLEARED (AS IT SAYS ON PRODUCT) LASER HAIR REMOVAL IPL VENUS SILK BRAUN GILLETTE AND NEXT DAY I WOKE UP WITH RED BLOBS ON MY SKIN ALL OVER THE APPLICATION AREAS INCLUDING MY ARMS AND LEGS. MY SKIN LOOKS LIKE IT IS BURNT PROBABLY 1ST DEGREE AND HAS REDDISH BIG EXTENSIVE MARKS ON IT. I HAVE EXTENSIVE ITCHING TOO AND THIS PRODUCT HAS DONE MORE HARM THEN ANY GOOD. I HAVE A HEALTHY SKIN AND NEVER HAD ANY PROBLEM BEFORE. I AM A HEALTHY PERSON BUT THIS SKIN REACTION ISN'T GOOD. THESE PRODUCTS ARE HARMFUL AND NEED TO BE BANNED BASED ON RESPONSE (I CAN PROVIDE THE PHOTOS) I COULDN'T STAY AT EASE AND IT ISN'T GOING AWAY. DUE TO COVID19 SITUATION IN (B)(6) I CANNOT MEET MY PHYSICIAN AS I AM TRYING TO SELF-QUARANTINE TO HAVE SOCIAL DISTANCING. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365435 LIGHT BASED OVER-THE-COUNTER HAIR REMOVAL LIGHT BASED OVER-THE-COUNTER HAIR REMOVAL OHT CYDEN LIMITED BD5006 8334A70321 6905588240

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R