BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTISOL

    MDR report key: 8191499 · Received December 20, 2018

    Report

    Report Number
    MW5082509
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    August 15, 2017
    Report Date
    December 19, 2018
    Manufacturer
    FERNDALE LABORATORIES, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD ARTHROSCOPIC SURGERY ON MY RIGHT SHOULDER, 3 INCISIONS. MASTISOL WAS APPLIED AROUND EACH OF THE INCISION SITES. WITHIN 48 HRS, MY INCISIONS WERE ITCHING SO BAD I HAD TO REMOVE THE BANDAGE. EACH OF THE INCISION SITES WERE A MASS OF DRAINING BLISTERS. YOU COULD LITERALLY WATCH THEM FORM AND POP. I KNEW THIS WAS AN ALLERGIC REACTION TO SOMETHING, SO I CLEANED IT UP AS BEST I COULD AND APPLIED SOME 1.5% CORTISONE FOAM TO TRY TO ALLEVIATE THE SEVERE ITCHING. I SAW THE SURGEON THE FOLLOWING MORNING AND HE WAS SHOCKED BY WHAT HE SAW. HE CHANGED THE DRESSING AND TOLD ME TO CONTINUE USING THE CORTISONE FOAM. AFTER ANOTHER 24 HRS, IT HAD IMPROVED SIGNIFICANTLY AND TOOK AN ADD'L 3 OR 4 DAYS TO MOSTLY DISAPPEAR. THERE IS NOW A NOTE IN MY RECORDS TO NEVER USE MASTISOL AGAIN. IT IS A LIQUID ADHESIVE TO AID SURGICAL DRESSINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027480 MASTISOL TAPE AND BANDAGE, ADHESIVE KGX FERNDALE LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR