BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBRACE SILICONE SCAR TREATMENT

    MDR report key: 18238556 · Received November 29, 2023

    Report

    Report Number
    MW5148580
    Event Type
    Injury
    Date Received
    November 29, 2023
    Date of Event
    October 10, 2023
    Report Date
    November 25, 2023
    Manufacturer
    NEODYNE BIOSCIENCES, INC.
    Product Code
    MDA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PRODUCT ADHESIVE CONTAINS LATEX (A LATEX ACCELERATOR). THE PRODUCT CAUSED A CHEMICAL BURN ON CONTACT. THE CHEMICAL BURN IS STILL PRESENT AND PAINFUL TWO WEEKS AFTER SKIN CONTACT. PRODUCT PACKAGING DOES NOT PROVIDE INGREDIENTS. PACKAGING DOES NOT INCLUDE A LATEX WARNING. PRODUCT REPRESENTATIVE TWICE REFUSED TO PROVIDE INGREDIENTS WHEN CONTACTED DIRECTLY. PRODUCT PACKAGING FALSELY CLAIMS THE PRODUCT IN ITS CURRENT FORM IS FDA CLEARED. THERE ARE MANY PRODUCT REVIEWERS ON AMAZON WHO HAVE EXPERIENCED A SIMILAR OR MORE SEVERE ALLERGIC REACTION. SEVERAL FEAR THE AREA OF CONTENT COULD HAVE A SECONDARY INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429447 EMBRACE SILICONE SCAR TREATMENT ELASTOMER, SILICONE, FOR SCAR MANAGEMENT MDA NEODYNE BIOSCIENCES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Life Threatening