BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORME REVIVE BRA

    MDR report key: 22125827 · Received June 2, 2025

    Report

    Report Number
    MW5170934
    Event Type
    Injury
    Date Received
    June 2, 2025
    Date of Event
    May 23, 2025
    Report Date
    May 23, 2025
    Manufacturer
    IFGCURE INC.
    Product Code
    LZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE COMPANY RECOMMENDS WEARING THE FORME BRA 7-10 HOURS A DAY AND ALL NIGHT FOR "MAXIMUM BENEFITS". THEY CLAIM IT HELPS WITH PAIN, POSTURE, AND HAS MUSCULOSKELETAL BENEFITS. THE FIRST WEEK I STARTED WEARING IT I REALLY LIKED IT AND FELT FINE, BUT AS THE WEEKS HAVE GONE ON MY PAIN HAS SLOWLY GOTTEN WORSE AND MY MUSCLES SEEM A LOT WEAKER THAN THEY WERE BEFORE I STARTED USING IT. NOW WHEN I DON'T WEAR THE BRA MY ARMS/SHOULDERS STRUGGLE TO DO BASIC STRETCHES THAT I USED TO DO EASILY. I'M CONCERNED THIS PRODUCT CAUSES THE UPPER BACK/SHOULDER MUSCLES TO WEAKEN WHEN YOU WEAR IT FOR THAT LONG WHICH RESULTS IN NEEDING TO WEAR THE BRA CONSTANTLY JUST TO FEEL "NORMAL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889597 FORME REVIVE BRA MONITOR, SPINE CURVATURE LZW IFGCURE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female BLACK ELDERBERRY.| CLARITIN.| CRANBERRY SUPPLEMENT.| IMITREX 100MG AS NEEDED FOR MIGRAINES.