BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTISOL ADHESIVE

    MDR report key: 3688188 · Received March 13, 2014

    Report

    Report Number
    MW5034972
    Event Type
    Injury
    Date Received
    March 13, 2014
    Date of Event
    March 8, 2014
    Report Date
    March 12, 2014
    Manufacturer
    FERNDALE LABORATORIES, INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD TOTAL KNEE REPLACEMENT ON (B)(6) 2014. THE OPERATING ROOM APPLIED MASTISOL ADHESIVE ALONG BOTH SIDES OF A 10 INCH INCISION TO HELP SECURE STERISTRIPS. WITHIN 5 DAYS DEVELOPED SEVERE ITCHING, REDNESS AND DIFFUSE BULLAE REQUIRING ADMINISTRATION OF ORAL STEROIDS AND PROPHYLACTIC ANTIBIOTICS TO PREVENT INFECTION. AM STILL AWAITING OUTCOME. IT HAS GREATLY AFFECTED MY PROGRESS WITH THERAPY. MY DOCTOR TOLD ME THAT I WAS THE SECOND PERSON SINCE (B)(4) OUT OF (B)(6) PATIENTS WHO DEVELOPED THIS TYPE OF REACTION. FREQUENCY: POST SURGERY, ROUTE: APPLIED TO A SURFACE, USUALLY THE SKIN. DATES OF USE: (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: TOPICAL SKIN ADHESIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151575 MASTISOL ADHESIVE MASTISOL KGX FERNDALE LABORATORIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other