BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTI-NAUSEA WRISTBAND, RECHARGEABLE RELIEVE NAUSEA MOTION SICKNESS BANDS, RELIEV

    MDR report key: 15959044 · Received December 9, 2022

    Report

    Report Number
    MW5113725
    Event Type
    Injury
    Date Received
    December 9, 2022
    Date of Event
    September 26, 2022
    Report Date
    December 8, 2022
    Manufacturer
    UNK
    Product Code
    MVV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I BOUGHT A MEDICAL TREATMENT WRISTBAND NAMED "ANTI-NAUSEA WRISTBAND, RECHARGEABLE RELIEVE NAUSEA MOTION SICKNESS BANDS, RELIEVE NAUSEA ELECTRODE STIMULATOR WRIST BANDS RELIEF FOR ANXIETY, MIGRAINE, MOTION SICKNESS" ON AMAZON RECENTLY. WEBSITE:HTTPS://WWW.AMAZON.COM/DP/B0B7B7G92P I USED THE WRISTBAND FOLLOW THE INSTRUCTIONS. UNFORTUNATELY IT MADE ME UNCOMFORTABLE AND I FOUND SOME ERYTHEMA AND BLISTERS APPEARED ON MY WRIST. I TOOK TWO PICTURES OF MY WRIST AND I PUT THEM IN THE ATTACHMENT OF THIS DOCUMENT. I SEARCHED THIS WRISTBAND NAME ON THE WEBSITE OF FDA ESTABLISHMENT REGISTRATION AND DEVICE LISTING AND 510(K) PREMARKET NOTIFICATION, BUT I COULD NOT GET ANY RECORDS IN FDA DATABASES. I WONDER HOW COULD AMAZON PERMIT THIS MEDICAL TREATMENT WRISTBAND SHELVED WITHOUT FDA ESTABLISHMENT REGISTRATION OR 510(K) PREMARKET NOTIFICATION. WHAT'S MORE, I COLLECTED SOME INFORMATION THROUGH IT'S WEB PAGE ON AMAZON. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2180635 ANTI-NAUSEA WRISTBAND, RECHARGEABLE RELIEVE NAUSEA MOTION SICKNESS BANDS, RELIEV DEVICE, ACUPRESSURE MVV UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Required Intervention| S NO PRESCRIPTION MEDICATIONS AND MEDICAL DEVICES BEING USED