BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTISOL

    MDR report key: 19683728 · Received July 3, 2024

    Report

    Report Number
    MW5157040
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 27, 2024
    Report Date
    June 30, 2024
    Manufacturer
    FERNDALE LABORATORIES, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I KNEW I HAD PREVIOUS REACTIONS TO MEDICAL TAPE/ADHESIVES. I HAD A SURGERY ON (B)(6) 2024. MY ALLERGY WAS IN MY CHART (AS "TAPE") AND ON MY ALLERGY BAND. MASTISOL WAS STILL USED TO PREP THE SURGICAL SITE. DURING MY 1 NIGHT HOSPITAL STAY I WAS BEING GIVEN PREDNISONE AND AN ANTIBIOTIC AND ONCE I WAS HOME ON (B)(6), I STARTED TO NOTICE A BIT OF A REACTION AROUND THE SURGICAL SITE. WITHIN A 10 HOURS, IT HAD SPREAD DOWN MY SHOULDERS, CHEST AND NECK (THE AREA THAT WAS PREPPED). MD (PHYSICIAN) SAID THEY USED MASTISOL. I WAS PUT BACK ON PREDNISONE (5 DAY COURSE), BENADRYL (24 HOURS). WHILE I UNDERSTAND THIS TYPE OF REACTION IS RARE, THIS IS NOW THE SECOND TIME I'VE EXPERIENCED IT IN A SURGICAL SETTING. THE SYMPTOMS OF SEVERE ITCHING, PAIN, SWELLING, BLISTERING ARE WORSE THAN THE SURGERY ITSELF. I WISH THIS WERE TAKEN MORE SERIOUSLY FROM A CLINICAL PERSPECTIVE AND NOT AS A SUPER RARE OCCURRENCE THAT MD'S AND TREATMENT TEAMS DISCARD. IT'S SOMETHING THAT SETS BACK RECOVERY AND WOUND HEALING. CHEMTREC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152398 MASTISOL TAPE AND BANDAGE, ADHESIVE KGX FERNDALE LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention| O BENADRYL.| DAILY VITAMIN TYLENOL (AS NEEDED).| FLEXERIL 10MG (3X DAY).| HYDROCORTISONE CREAM.| MAGNESIUM ARNICA BENADRYL EXTRA STRENGTH. | PREDNISONE (5 DAY COURSE, ON DAY 3).| XANAX 0.25MG (AS NEEDED).