BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTISOL LIQUID ADHESIVE

    MDR report key: 4231699 · Received November 2, 2014

    Report

    Report Number
    MW5038960
    Event Type
    Injury
    Date Received
    November 2, 2014
    Date of Event
    September 25, 2014
    Report Date
    November 2, 2014
    Manufacturer
    FERNDALE LABORATORIES INC.
    Product Code
    MPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MASTISOL LIQUID ADHESIVE WAS UTILIZED ON THIS BREAST REDUCTION PATIENT AS PART OF THE DRESSING TO COVER THE SURGICAL SITE INCISION. THE MASTISOL IS BELIEVED TO HAVE CAUSED HER SEVERE SECOND DEGREE BURNS WHICH CAUSED HER TO HAVE FURTHER WOUND DEBRIDEMENT TREATMENTS FOLLOWING HER SURGERY PROLONGING HER RECOVERY TIME. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700769 MASTISOL LIQUID ADHESIVE LIQUID ADHESIVE MPN FERNDALE LABORATORIES INC. MASTISOL VIAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other