BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTISOL, STERISTRIPS

    MDR report key: 12107501 · Received July 1, 2021

    Report

    Report Number
    MW5102251
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    June 24, 2021
    Report Date
    June 29, 2021
    Manufacturer
    FERNDALE LABORATORIES, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2021, HAD SURGERY TO PLATE RIGHT RADIUS/ULNA FRACTURE. ON OR AROUND (B)(6) 2021, FELT HOT, RASH AND BLISTERS UNDER CAST. ON (B)(6) 2021 WENT TO NORMAL ORTHOPEDIC SURGICAL FOLLOW UP AND FOUND ALLERGIC CONTACT DERMATITIS (ACD) IN THE AREA WHERE MASTISOL WAS APPLIED TO CLOSE WOUND WITH STERISTRIPS. LARGE FLUID-FILLED BULLAE ARE PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994500 MASTISOL, STERISTRIPS TAPE AND BANDAGE, ADHESIVE KGX FERNDALE LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention