BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIATREI MOTION SICKNESS BANDS

    MDR report key: 18437557 · Received January 2, 2024

    Report

    Report Number
    MW5149744
    Event Type
    Injury
    Date Received
    January 2, 2024
    Date of Event
    December 27, 2023
    Report Date
    December 28, 2023
    Manufacturer
    UNK
    Product Code
    MVV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED A PIATREI MOTION SICKNESS BANDS FROM AMAZON.COM ASIN: (B)(6). AFTER USING, I FELT MY HEART RACING, SHORTNESS OF BREATH, AND EVEN FAINTED. THIS PRODUCT IS ADVERTISED TO BE FDA APPROVED, I LOOKED FOR THIS PRODUCT IN THE FDA DATABASE BUT COULD NOT FIND IT, I FELT I WAS BEING SCAMMED AND EVEN ENDANGERED MY LIFE. CAN THE FDA REGULATE MEDICAL PRODUCTS SOLD ON AMAZON SHELVES MORE TO PROTECT CONSUMERS' LIVES? (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585662 PIATREI MOTION SICKNESS BANDS DEVICE, ACUPRESSURE MVV UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Life Threatening