BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBRACE SCAR THERAPY

    MDR report key: 9271670 · Received November 1, 2019

    Report

    Report Number
    MW5090842
    Event Type
    Injury
    Date Received
    November 1, 2019
    Date of Event
    October 29, 2019
    Report Date
    October 30, 2019
    Manufacturer
    NEODYNE BIOSCIENCES, INC.
    Product Code
    MDA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A BREAST REDUCTION / LIFT SURGERY 13 WEEKS AGO. I WAS HAPPY WITH MY RESULTS, BUT WANTED TO DO EVERYTHING I COULD IN ORDER TO PREVENT SCARRING. I RESEARCHED ABOUT EMBRACE SCAR THERAPY AND LIKED THAT IT WAS FDA APPROVED AND SHOWED POSITIVE RESULTS IN CLINICAL TRIALS. I ASKED MY PLASTIC SURGEON WHAT HE THOUGHT, AND HE RECOMMENDED I USE THE PRODUCT. AFTER MY FIRST APPLICATION (60 DAYS ARE RECOMMENDED) I NOTICED BLISTERING, BURNING, RASHES, AND EVEN CHUNKS OF MY SKIN THAT HAD PEELED OFF ONTO THE SILICONE STRIPS. MY BREASTS LOOK TOTALLY DISFIGURED NOW, AND THEY WERE AMAZING BEFORE I USED THIS PRODUCT. IT EVEN HAS 2.8 OUT OF 5 STAR RATING ON (B)(6). CAN'T BELIEVE THIS IS FDA APPROVED, IT COMPLETELY RUINED MY (B)(6) SURGERY AND MY SELF ESTEEM. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? NO. DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN? DOESN'T APPLY. DATES OF USE: (B)(6) 2019. PRODUCT TYPE: OVER-THE-COUNTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064047 EMBRACE SCAR THERAPY ELASTOMER, SILICONE, FOR SCAR MANAGEMENT MDA NEODYNE BIOSCIENCES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other