BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTISOL LIQUID ADHESIVE

    MDR report key: 1951105 · Received December 29, 2010

    Report

    Report Number
    MW5018840
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    December 21, 2010
    Report Date
    December 29, 2010
    Manufacturer
    FERNDALE LABORATORIES, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER HAVING A LAPAROSCOPIC CHOLECYSTECTOMY, I DEVELOPED A SEVERE ALLERGIC REACTION TO A PRODUCT CALLED MASTISOL LIQUID ADHESIVE. THIS IS THE FIRST TIME I RECALL A DOCTOR USING MASTISOL LIQUID ADHESIVE ON ME AFTER SURGERY. MY LAST SURGICAL PROCEDURE WAS A CAESARIAN IN 2004 AND I HAD NO ADVERSE REACTION TO THE STERI-STRIPS, BANDAGES, OR ADHESIVES USED. MY SYMPTOMS INCLUDE A DARK RED PATCH APPROX 1.5 - 2 INCH DIAMETER AROUND ALL FOUR LAPAROSCOPIC INCISIONS. EACH AREA IS RAISED ABOVE THE SURFACE OF THE SKIN AND ITS ITCHY AND HOT. ADDITIONALLY, TWO OF THE AFFECTED AREAS HAVE CHICKENPOX SIZE BLISTER CLUSTERS WITHIN THAT SAME DIAMETER. I WAS SEEN BY MY DOCTOR ON (B)(6) 2010, 8 DAYS POST OP, AND HE PRESCRIBED TRIAMCINOLONE CREAM, LORATADINE, AND AN ANTIHISTAMINE TO HELP WITH THE SYMPTOMS. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASTISOL LIQUID ADHESIVE NONE KGX FERNDALE LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other