BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBRACE SCAR THERAPY FOR OLD SCARS

    MDR report key: 16234484 · Received January 23, 2023

    Report

    Report Number
    MW5114459
    Event Type
    Injury
    Date Received
    January 23, 2023
    Date of Event
    January 13, 2023
    Report Date
    January 19, 2023
    Manufacturer
    NEODYNE BIOSCIENCES, INC
    Product Code
    MDA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I BOUGHT THE EMBRACE SCAR THERAPY LONG STRIPS FOR OLDER SCARS. I CLEANED THE AREA OF USE LET IT DRY AND PUT ON AS INSTRUCTED. I HAD TO USE FOUR STRIPS BECAUSE MY SCAR IS HIP TO HIP. THE DATE OF APPLICATION WAS TUESDAY (B)(6) 2023. THE NEXT DAY I WASN'T FEELING TO WELL BUT NEVER EQUATED IT TO THE EMBRACE SCAR STRIPS. HOWEVER EVERYDAY I FELT PROGRESSIVELY WORSE TO THE POINT THAT I FELT FAINT AND LIKE I MAY NEED TO GO TO THE HOSPITAL BECAUSE I WAS UNSURE OF EXACTLY WHAT WAS WRONG. THOUGH I VISITED MY DOCTOR ON FRIDAY, (B)(6) 2023, BECAUSE I WASN'T FEELING WELL AGAIN, I NEVER EQUATED IT TO SCAR STRIPS. WHEN I GOT HOME FROM MY DOCTOR'S VISIT I DECIDED TO REMOVE THE STRIPS AS THEY WERE ALREADY COMING OFF AFTER THE FIRST DAY OF APPLICATION I MANAGE TO KEEP THEM ON FOR 3 DAYS. UPON REMOVAL I NOTICED HUGE BLISTERS ON AND AROUND MY SCAR THAT LOOK LIKE BURNS WHEN I TOUCHED THE SCAR ITSELF MY SKIN CAME OFF ON MY FINGERS. SINCE REMOVAL OF THE STRIPS I HAVE BEEN GETTING PROGRESSIVELY BETTER NOT FEELING SICK BUT I AM SELF TREATING MY SCARS FROM THE SCAR STRIPS. IT'S AFTER THE HOLIDAY NOW AND I WILL REPORT IT TO MY DOCTOR AS OF TODAY, TUESDAY (B)(6) 2023. I DID MAKE THE EMBRACE COMPANY AWARE AND SUPPLIED THEM WITH PICTURES THEY EMAILED ME A RECEIPT STATING THAT THEY WERE REFUNDING MY MONEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785821 EMBRACE SCAR THERAPY FOR OLD SCARS ELASTOMER, SILICONE, FOR SCAR MANAGEMENT MDA NEODYNE BIOSCIENCES, INC 30977391

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention MULTIVITAMIN | VITAMIN D