BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBRACE SCAR THERAPY

    MDR report key: 13093312 · Received December 27, 2021

    Report

    Report Number
    MW5106286
    Event Type
    Injury
    Date Received
    December 27, 2021
    Date of Event
    December 1, 2018
    Report Date
    December 22, 2021
    Manufacturer
    NEODYNE BIOSCIENCES, INC.
    Product Code
    MDA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I APPLIED THE EMBRACE SCAR STRIPS A COUPLE OF MONTHS AFTER MY SURGERY TO REDUCE SCARRING. THE ADHESIVE THAT KEEPS THE STRIP ADHERED TO THE BODY CAUSED ME TO HAVE SHARP AND BURNING PAIN. UPON REMOVAL I NOTICED BLISTERS, RED RASH AND SKIN ULCERS. THIS WAS ON LARGE AREAS OF SKIN AS THE STRIPS WERE USED IN MULTIPLE AREAS AT ONCE AND THEY WERE LARGE IN SIZE. I DISCONTINUED USAGE OF THE PRODUCT AND CONTACTED THE COMPANY. I EXPERIENCED SCARRING THAT FROM THE BLISTERS AND ULCERS, WHICH EVENTUALLY IMPROVED AFTER SEVERAL MONTHS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986118 EMBRACE SCAR THERAPY ELASTOMER, SILICONE, FOR SCAR MANAGEMENT MDA NEODYNE BIOSCIENCES, INC. 27720385

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female