BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTISOL LIQUID ADHESIVE

    MDR report key: 2792474 · Received September 27, 2012

    Report

    Report Number
    1811212-2012-00001
    Event Type
    Injury
    Date Received
    September 27, 2012
    Date of Event
    July 26, 2012
    Report Date
    September 6, 2012
    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 #: 0523-XX, LOT #: UNK. A PT REPORTED AN ADVERSE REACTION THROUGH THE FDA'S MEDWATCH PROGRAM. REPORT # (B)(4) WAS REC'D FROM THE FDA ON (B)(4) 2012. A PT HAD A MOLE REMOVED ON (B)(6) 2012 BY THEIR DERMATOLOGIST. THE SUTURE WAS REMOVED TWO WEEKS LATER AND MASTISOL WAS USED WITH STERI-STRIPS ON THE SCAR. A PAINFUL RASH WITH PUS DEVELOPED WITHIN 24 HRS OF APPLICATION. THE PT VISITED A (B)(4) FACILITY THE NEXT DAY AND WAS TREATED WITH A STEROID SHOT. A FEW DAYS LATER, THE PT BEGAN TO DEVELOP HIVES DUE TO THE REACTION. NO CONTACT INFO WAS PROVIDED BY THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other