BEUDAMED
    FDA Adverse Event Summary report: N

    MASTISOL LIQUID ADHESIVE

    MDR report key: 2923257 · Received January 4, 2013

    Report

    Report Number
    1811212-2012-00003
    Date Received
    January 4, 2013
    Date of Event
    November 28, 2012
    Report Date
    January 3, 2013
    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

    PRODUCT: MASTISOL LIQUID ADHESIVE. ITEM #: (B)(4). LOT #: UNKNOWN. A MALE PT CONTACTED FLI TO REPORT AN ADVERSE EVENT (ITCHING, REDNESS AND BLISTERING) ASSOCIATED WITH MASTISOL LIQUID ADHESIVE. THE PT HAD ARTHROSCOPIC SURGERY ON HIS RIGHT SHOULDER ON TUESDAY, (B)(6) 2012. MASTISOL LIQUID ADHESIVE WAS USED AT ALL THREE INCISION SITES. HE DEVELOPED AN ITCHY, BLISTERY RASH WITH WHITE FLUID FILLED BLISTERS APPROXIMATELY 2-3" IN DIAMETER AT THE INCISION SITES. ON TUESDAY, (B)(6) 2012, HE HAD AN APPOINTMENT WITH HIS GENERAL PRACTITIONER REGARDING THE REACTION. THE PHYSICIAN PRESCRIBED HYDROXYZINE HCL (ANTIHISTAMINE) AND A METHYLPREDNISOLONE DOSE PACK FOR THE REACTION. THE PT NOTED HIS REACTION IS MUCH BETTER BUT THE AREA IS STILL RED AND ITCHY. NO LOT NUMBER OR PACKAGING CONFIGURATION WAS PROVIDED TO FLI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5514 MASTISOL LIQUID ADHESIVE LIQUID ADHESIVE KGX FERNDALE LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR