BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTISOL

    MDR report key: 8306201 · Received February 4, 2019

    Report

    Report Number
    MW5083694
    Event Type
    Injury
    Date Received
    February 4, 2019
    Date of Event
    January 4, 2019
    Report Date
    February 1, 2019
    Manufacturer
    FERNDALE LABORATORIES, INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MASTISOL GLUE WAS APPLIED TO SECURE STERI-STRIPS TO HOLD 2 INCISIONS TOGETHER AFTER STITCHES WERE REMOVED. I EXPERIENCED SEVERE RASH, BLISTERING, AND OOZING FOR 2 WEEKS FOLLOWING. NOTE CONSUMER REPORTS ON MASTISOL ON WEBMD: 74 REPORTS OF SAME PROBLEMS I HAD. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96551 MASTISOL TAPE AND BANDAGE, ADHESIVE KGX FERNDALE LABORATORIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other