BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMAWAND

    MDR report key: 12150116 · Received July 12, 2021

    Report

    Report Number
    MW5102455
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    April 14, 2021
    Report Date
    July 9, 2021
    Manufacturer
    / SOMETHING HIGH ELECTRIC (XIAMEN) COMPANY, LTD.
    Product Code
    NZF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUT ON FACE BY DEVICE; I HAVE HAD A DERMAWAND SKIN TREATMENT DEVICE FOR SEVERAL YEARS NOW. THE FIRST ONE HAD THE BULB POP OPEN WHEN I TURNED IT ON SO THE COMPANY REPLACED IT. THE SECOND ONE HAD THE BULB EXPLODE WHILE IT WAS AT MY CHEEK AND IT CUT MY CHEEK. I CONTACTED THE COMPANY AND THEY WERE SO ATTENTIVE, THEN WHEN I COULD NOT FIND THE RECEIPT IN SPITE OF THE PICTURES OF IT BEING THEIR PRODUCT AND THE INJURY THEY FLUFFED ME OFF. THEY ALSO MAKE IT SO ONCE YOU CLOSE AN EMAIL YOU CANNOT SEE A REPLY. THEY DID NOT FOLLOW THROUGH AS THEY AGREED. I COULD HAVE LOST MY EYE. SOMEONE MAY LIKELY LOOSE OR DAMAGE THEIR SIGHT OR EVEN CUT A CRANIAL NERVE OR ARTERY. THEY NEED TO TAKE RESPONSIBILITY, I AM WELL OFF AND A HIGHLY EDUCATED PROFESSIONAL. THIS PRODUCT IS DANGEROUS AND THE COMPANY HAS NO WARNING THAT THE GLASS BULB MIGHT EXPLODE NEAR THE FACE. TO DATE THEY HAVE DONE ZERO TO ATTEND TO OR COMPENSATE FOR THE HARM IT CAUSED ME LET ALONE WHAT MAY HAVE HAPPENED. I DO NOT KNOW ABOUT THEIR TESTING. I HAVE A STRAND OF EMAILS AND PICTURE OF WHAT HAPPENED. DERMAWAND BRANDSTREET MARKETING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045810 DERMAWAND STATIC ELECTRICITY-EMITTING DEVICE, COSMETIC USE NZF / SOMETHING HIGH ELECTRIC (XIAMEN) COMPANY, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other MULTI VITAMIN | SYNTHROID