BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFGFIT WEARABLE TECH PRODUCTS FOR POSTURAL IMPROVEMENT FORME POWER BRA

    MDR report key: 12384813 · Received August 27, 2021

    Report

    Report Number
    MW5103564
    Event Type
    Injury
    Date Received
    August 27, 2021
    Date of Event
    July 24, 2021
    Report Date
    August 25, 2021
    Manufacturer
    IFGFIT INC.
    Product Code
    LZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED THE BRA AND TRIED IT FOR A FEW HOURS UNWASHED WITH THE TAGS ON. I NOTICED THAT IT ITCHED AND I HAD REDNESS, SO I WASHED IT IN THE FINE WASHABLES (HAND WASH) SOAP, I USE FOR ALL OF MY RUNNING / YOGA GARMENTS. I THEN WORE IT AGAIN, AND I STILL HAD THE SAME RED/ITCHINESS UNDER MY ARMPITS AND AROUND THE SEAMS. I THOUGHT MAYBE IT WAS THE TAG THAT WAS BOTHERING ME, SO AGAIN, TOOK IT OFF, RE-HAND WASHED IT WITH A LONG RINSE/SOAK, CUT THE INSIDE SMALL TAG (I STILL HAVE IT THOUGH) AND TRIED IT AGAIN THE FOLLOWING DAY. SAME THING HAPPENED. BECAUSE THIS NEVER HAPPENED BEFORE WITH ANY MATERIAL, I AM PROBABLY REACTING TO THE MATERIAL OR THE MATERIAL USED TO STITCH THE SEAMS. THE REDNESS/SWELLING DID GET WORSE IF I LEFT THE GARMENT ON. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277892 IFGFIT WEARABLE TECH PRODUCTS FOR POSTURAL IMPROVEMENT FORME POWER BRA MONITOR, SPINE CURVATURE LZW IFGFIT INC. POWER BRA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other