BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTISOL

    MDR report key: 11805428 · Received May 10, 2021

    Report

    Report Number
    MW5101262
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    April 22, 2021
    Report Date
    May 6, 2021
    Manufacturer
    FERNDALE LABORATORIES, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD NOSE SURGERY AND MASTISOL WAS PLACED TO KEEP TAPE AND CASTE ON TOP OF MY NOSE IN PLACE. THREE (3) DAYS AFTER MY SURGERY I NOTICED A RED RASH FORMING AROUND THE TAPE. ON DAY FOR IT FELT LIKE MY NOSE WAS ON FIRE, SO I CALLED MY SURGEON AND WAS ADVISED TO REMOVE THE TAPE AND CASTE, AND TO REMOVE THE ADHESIVE WITH ACETONE. MY SKIN WAS SO RED AND SWOLLEN, AND OOZING. I FOLLOWED UP IN OFFICE 3 DAYS LATER AND MY SURGEON SAID IT WAS THE WORST SKIN REACTION TO ADHESIVE THAT HE'S EVER SEEN, AND THAT WAS 3 DAYS AFTER I'D REMOVED THE ADHESIVE. I WAS EVEN TAKING A MEDROL DOSE PACK AND DAILY ANTIHISTAMINE POST SURGERY. THE RASH HAS GOTTEN BETTER WITH DAILY HYDROCORTISONE 1%; 14 DAYS AFTER ADHESIVE REMOVAL AND RASH STILL NOT FULLY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699583 MASTISOL TAPE AND BANDAGE, ADHESIVE KGX FERNDALE LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR