BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTISOL

    MDR report key: 8325328 · Received February 8, 2019

    Report

    Report Number
    MW5083864
    Event Type
    Injury
    Date Received
    February 8, 2019
    Date of Event
    December 18, 2018
    Report Date
    February 7, 2019
    Manufacturer
    FERNDALE LABORATORIES, INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD ANKLE SURGERY AND HAD STERI-STRIPS AND MASTISOL USED ON THE SITE. AFTER TWO WEEKS INTENSE ITCHING STARTED, EVERYTHING WAS REMOVED AND WIPED WITH ALCOHOL. THERE WAS MODERATE REDNESS. CORTISONE AND COMPRESSION BANDAGES WERE APPLIED. THE FOLLOWING WEEK IT TURNED INTO A SEVERE, BLISTERED, INTENSELY ITCHY PATCH ABOUT 4 IN WIDE THAT LASTED FOR OVER A MONTH. THE ALCOHOL WIPING HAD NOT REMOVED IT ENTIRELY AND INSTEAD PUSHED IT AROUND, LEAVING RED MARKS IN THE SHAPE OF THE WIPING AT THE EDGES OF THE PATCH. OTHER SERIOUS/IMPORTANT MEDICAL INCIDENTS: EXTREME ALLERGIC DERMATITIS. HOW WAS IT TAKEN OR USED? TOPICAL. THERAPY DURATION: 2 WEEKS. WHY WAS THE PERSON USING THE PRODUCT? SURGICAL SITE ADHESIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112355 MASTISOL TAPE AND BANDAGE, ADHESIVE KGX FERNDALE LABORATORIES, INC
    112356 STERI-STRIPS TAPE AND BANDAGE, ADHESIVE KGX 3M COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other