BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTISOL

    MDR report key: 15016428 · Received July 13, 2022

    Report

    Report Number
    MW5110863
    Event Type
    Injury
    Date Received
    July 13, 2022
    Date of Event
    June 29, 2022
    Report Date
    July 12, 2022
    Manufacturer
    FERNDALE LABORATORIES, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MASTISOL APPLIED AFTER CANCER SURGERY TO ADHERE BANDAGE TO CHEST AREA. WITHIN HOURS SKIN BEGAN TO HAVE EXTREME ITCHING, EXTREME BURNING SENSATION, SKIN BECAME INFLAMED RED COLOR. TWENTY-FOUR HOURS LATER BANDAGE WAS REMOVED AND DISCOVERED THE BANDAGE HAD MELTED AND GLUE SUBSTANCE WAS STUCK TO SKIN. REQUIRED GOO-GONE, MINERAL OIL TO REMOVE MELTED MATERIAL. EXTREME ITCHING AND BURNING SENSATION CONTINUED FOR ABOUT 5 DAYS. APPLIED VARIOUS TOPICAL TREATMENTS TO MITIGATE THE PAIN. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959743 MASTISOL TAPE AND BANDAGE, ADHESIVE KGX FERNDALE LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other SIMVATATIN