BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-NAUSEA WRISTBAND

    MDR report key: 15690972 · Received October 27, 2022

    Report

    Report Number
    MW5112958
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    September 29, 2022
    Report Date
    October 26, 2022
    Manufacturer
    UNKNOWN
    Product Code
    MVV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECENTLY BOUGHT A "ANTI-NAUSEA WRISTBAND, RECHARGEABLE RELIEVE NAUSEA MOTION SICKNESS BANDS ,RELIEVE NAUSEA ELECTRODE STIMULATOR WRIST BANDS RELIEF FOR ANXIETY, MIGRAINE, MOTION SICKNESS (CAR, AIR, TRAIN, SEA)" IS A MEDICAL WRISTBAND. ASIN: (B)(4) LINK: HTTPS://WWW.AMAZON.COM/DP/(B)(4) I USED THE WRISTBAND ACCORDING TO THE INSTRUCTIONS. UNFORTUNATELY, IT MADE ME UNCOMFORTABLE AND I NOTICED SOME REDNESS AND BLISTERS ON MY WRIST. I TOOK TWO PHOTOS OF THE APPEARANCE OF THE ADVERSE REACTION AND PLACED THEM IN THE ATTACHMENT TO THIS DOCUMENT. I SEARCHED THE FDA WEBSITE FOR THE NAME OF THIS WRISTBAND, BUT I HAVE NO RECORD OF IT IN THE FDA DATABASE. THIS PRODUCT IS A CLASS II MEDICAL DEVICE IN THE UNITED STATES. HOW DID IT MANAGE TO BE SOLD IN THE US SALES MARKET TO THE AVERAGE AMERICAN USER WITHOUT FDA REGISTRATION OR OBTAINING A 510(K) PREMARKET NOTIFICATION. I HAVE SUFFERED SEVERE ADVERSE REACTION EXPERIENCES AND WOULD LIKE THIS PRODUCT TO BE FDA SAFE FOR REGULATION. PLEASE PROHIBIT THE SALE OF THIS PRODUCT UNTIL IT IS APPROVED SO THAT IT DOES NOT POSE A THREAT TO THE SAFETY OF MORE USERS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2702695 ANTI-NAUSEA WRISTBAND DEVICE, ACUPRESSURE MVV UNKNOWN NOT MARKED NOT MARKED

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male Other