BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCARAWAY SILICONE SHEETS

    MDR report key: 21054484 · Received January 2, 2025

    Report

    Report Number
    MW5164100
    Event Type
    Injury
    Date Received
    January 2, 2025
    Date of Event
    December 20, 2024
    Report Date
    December 24, 2024
    Manufacturer
    ALLIANCE PHARMA INC.
    Product Code
    MDA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I APPLIED THIS DRESSING TO MY INCISION 5 WEEKS POST-OP. I APPLIED IT AFTER MY SHOWER BEFORE GOING TO BED AND AWOKE TO A HORRIBLE REACTION. I HAVE A RASH COMBINED WITH BLISTERED SKIN, MY CLOSED INCISION IS NOW SEEPING FLUIDS. I HAVE A KNOWN ADHESIVE ALLERGY TO CERTAIN TYPES OF ACRYLIC BASED ADHESIVES, I DO NOT HAVE AN ALLERGY TO SILICONE. THESE ARE LABELED AS 100% MEDICAL GRADE SILICONE. MY PHYSICIAN HAS PUT ME ON 3 MEDICATIONS TO COMBAT THE REACTION AND POTENTIAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553750 SCARAWAY SILICONE SHEETS ELASTOMER, SILICONE, FOR SCAR MANAGEMENT MDA ALLIANCE PHARMA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female ESTRADIOL PATCH| IRON| SELENIUM| VITAMIN D3