BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEES DEESS GP586 PERMANENT HAIR REMOVAL DEVICE, 350,000 FLASHES HOME USE, IPL HA

    MDR report key: 8842270 · Received July 29, 2019

    Report

    Report Number
    MW5088476
    Event Type
    Injury
    Date Received
    July 29, 2019
    Date of Event
    July 22, 2019
    Report Date
    July 26, 2019
    Manufacturer
    SHENZHEN GSD TECH CO., LTD
    Product Code
    OHT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY SKIN WAS SEVERELY BURNED AFTER A FEW MINUTES FROM THIS (B)(6) PRODUCT. I HAD TO SEE A DR, I HAVE BURN MARKS ON MY FACE. I CONTACTED THE (B)(6) AND THEY TOLD ME, WE DON'T CARE ABOUT PROFANITY DEESS GP586 PERMANENT HAIR REMOVAL DEVICE, 350,000 FLASHES HOME USE, IPL HAIR REMOVAL SYSTEM FOR FACE AND BODY, 2 IN 1 [HAIR REMOVAL, SKIN REJUVENATION]. MY SKIN IS BURNED AND BUBBLY. I RETURNED THE PRODUCT AS IT HAD A 30 DAY REFUND. THE COMPANY CLAIMS NO RESPONSIBILITY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628729 DEES DEESS GP586 PERMANENT HAIR REMOVAL DEVICE, 350,000 FLASHES HOME USE, IPL HA LIGHT BASED OVER THE COUNTER HAIR REMOVAL OHT SHENZHEN GSD TECH CO., LTD GP586

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention