BEUDAMED
    FDA Adverse Event Other Summary report: N

    MASTISOL LIQUID ADHESIVE

    MDR report key: 2326191 · Received August 11, 2011

    Report

    Report Number
    1811212-2011-00001
    Event Type
    Other
    Date Received
    August 11, 2011
    Date of Event
    March 19, 2011
    Report Date
    August 11, 2011
    Manufacturer
    FERNDALE LABORATORIES, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    GIVEN THE DIFFUSE NATURE OF THIS ERUPTION, ALTHOUGH THE DERMATOLOGY CONSULTANT CANNOT ABSOLUTELY EXCLUDE THAT THIS EVENT STARTED DUE TO AN ADHESIVE REACTION TO MASTISOL AND/OR TEGADERM COMBINATION IT IS UNLIKELY, AND THE DERMATOLOGY CONSULTANT TENDED TO FAVOR THE FORMER (USE OF SYSTEMIC MEDICATION) ETIOLOGY. NONETHELESS THE RIGHT THIGH AREA THAT WAS MORE DRAMATICALLY AFFECTED THAN OTHER SITES MAY REFLECT THE ROLE OF MASTISOL/TEGADERM AS A CONFOUNDING FACTOR. THE OCCLUSIVE QUALITY OF THE DRESSING MATERIAL FREQUENTLY YIELDS GAPS THAT FOSTER BACTERIAL OVERGROWTH THAT WOULD EXPLAIN THE FOCAL AREA OF PURULENCE ASSOCIATED WITH THE DRESSING SITE WHICH WAS NOTABLY WORSE THAN OTHER DIFFUSE RASH AREAS OVER THE ENTIRE BODY. IN ADDITION, THE POSSIBILITY OF IV INFILTRATION AS A CONTRIBUTING FACTOR AT THIS RIGHT THIGH SITE CANNOT BE EXCLUDED.

    Description of Event or Problem · 1

    PRODUCT: MASTISOL LIQUID ADHESIVE, ITEM #: 0523-48, LOT #: 10063B. AN ANESTHESIOLOGY NURSE FROM (B)(6) HOSP CONTACTED FLI ON (B)(6) 2011 TO REPORT AN ADVERSE EVENT ASSOCIATED WITH MASTISOL LIQUID ADHESIVE. A (B)(6) FEMALE HAD A RIGHT ANKLE ORIF PERFORMED. MASTISOL LIQUID ADHESIVE WAS USED TO SECURE TEGADERMS FOLLOWING A RIGHT SCIATIC NERVE BLOCK. THE PT HAD A SEVERE RASH THAT SPREAD FROM THE APPLICATION SITE, TO HER LEFT LEG, RIGHT FOREARM, FACE AND FINALLY TO BOTH OF HER EARS. DUE TO THE SEVERITY OF THE RASH SHE WENT TO ER AND WAS TREATED WITH IV STEROIDS AND SENT HOME. THE PT WAS NOT ADMITTED. THE NURSE NOTED THE PT HAD THE ADHESIVE IN CONTACT WITH HER SKIN FOR A SHORT AMOUNT OF TIME. MEDICAL CONSULT WAS RECEIVED ON (B)(4) 2011: THE CASE WAS EVALUATED BY A DERMATOLOGY CONSULTANT AND WAS DEEMED TO PROBABLY HAVE BEEN A MEDICATION REACTION OR A REACTION TO THE MASTISOL/TEGADERM COMBINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASTISOL LIQUID ADHESIVE MASTISOL KGX FERNDALE LABORATORIES, INC. 10063B

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization