BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEACTIVE PLUS

    MDR report key: 16051268 · Received December 23, 2022

    Report

    Report Number
    MW5114005
    Event Type
    Malfunction
    Date Received
    December 23, 2022
    Report Date
    December 7, 2022
    Manufacturer
    NATURES PILLOWS, INC. AND TOP DOG DIRECT, LLC
    Product Code
    PMV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HTTPS://WWW.GETBEACTIVEPLUS.CA/. CLAIMS THAT THE PRODUCT IS FDA APPROVED AS A BREAKTHROUGH PAIN DEVICE. CANNOT FIND ANYTHING ON FDA WEBSITE TO SUBSTANTIATE THIS CLAIM. ORDERED THE PRODUCT AND DOES NOT WORK AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2742255 BEACTIVE PLUS ORTHOSIS, LIMB, FOR BACK PAIN PMV NATURES PILLOWS, INC. AND TOP DOG DIRECT, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male