BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTISOL

    MDR report key: 8692788 · Received June 11, 2019

    Report

    Report Number
    MW5087301
    Event Type
    Injury
    Date Received
    June 11, 2019
    Report Date
    June 8, 2019
    Manufacturer
    FERNDALE LABORATORIES, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD GOTTEN MY NEXPLANON IMPLANT REMOVED FROM MY ARM 5 DAYS AGO, AND YESTERDAY I REALIZED THE MASTISOL THAT WAS USED ON MY WOUND CLOSURE CAUSED A WELT TO FORM UNDERNEATH THE STERI-STRIPS THAT WERE PLACED ON MY ARM. I'VE YET TO BE DIAGNOSED WITH ANYTHING CONCERNING THIS ISSUE, BUT I FELT THAT THE ALLERGY /ISSUE STILL NEEDED TO BE SHARED WITH THE FDA. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479198 MASTISOL TAPE AND BANDAGE, ADHESIVE KGX FERNDALE LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR