BEUDAMED
    FDA Adverse Event Other Summary report: N

    MASTISOL LIQUID ADHESIVE

    MDR report key: 2439645 · Received January 19, 2012

    Report

    Report Number
    1811212-2011-00002
    Event Type
    Other
    Date Received
    January 19, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 22, 2011
    Manufacturer
    FERNDALE LABORATORIES, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A PT CONTACTED FERNDALE LABORATORIES, INC VIA EMAIL ON (B)(6) 2011, TO REPORT AN ADVERSE EVENT (ITCHING, BLISTERING, OOZING, SWELLING AND SKIN DISCOLORATION) ASSOCIATED WITH MASTISOL LIQUID ADHESIVE LOT 10032A. THE FEMALE PT HAD A PRECANCEROUS MOLE REMOVED FROM HER MID CALF (B)(6) WEEKS AGO AND WENT BACK TO THE DERMATOLOGIST ON (B)(6) 2011, TO HAVE MORE OF THE AREA REMOVED. AFTER REMOVAL, THE PHYSICIAN APPLIED MASTISOL IN A SQUARE PATTERN WITH A Q-TIP TO SECURE DRESSING. THE LEG WAS WRAPPED WITH A PRESSURE BANDAGE. TAPE/STERI-STRIPS WERE NOT USED ON THE AREA. THE PT CHANGED HER DRESSING ON ((B)(6) 2011) AND NOTICED LARGE, OOZING BLISTERS. THE AREA WAS ALSO ITCHY. THE REACTION SEEMED TO SPREAD BY ((B)(6) 2011) AND SHE SPOKE WITH THE PHYSICIAN ON CALL. THE PHYSICIAN SWITCHED HER ANTIBIOTIC. SHE WENT TO THE ER ON (B)(6) BECAUSE THE REACTION GOT WORSE. ADD¿L BLISTERS, OOZING AND SWELLING WERE NOTED. THE ER GAVE HER PREDNISONE WHICH DID NOT HELP. ON ((B)(6) 2011), SHE RETURNED TO THE DERMATOLOGIST AND WAS GIVEN A STEROID CREAM (NAME UNK). THE BLISTERS AND OOZING ARE IMPROVING BUT ITCHING AND DISCOLORATION (RED/PURPLE) ARE BOTH UNCHANGED. PHOTOS OF THE REACTION WERE PROVIDED BY THE PT AND FORWARDED TO FLI¿S CONSULTING PHYSICIAN. THE PT REPORTED NO OTHER KNOWN ALLERGIES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASTISOL LIQUID ADHESIVE MASTISOL KGX FERNDALE LABORATORIES, INC. 10032A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O