BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTISOL

    MDR report key: 4025062 · Received August 11, 2014

    Report

    Report Number
    MW5037800
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 10, 2014
    Manufacturer
    FERNDALE LABORATORIES INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MASTISOL ADHESIVE WAS USED TO BETTER SECURE DRESSING / STERI-STRIPS AFTER ORTHOPEDIC SURGERY TO REMOVE HARDWARE IN KNEE AND CLAVICLE AREA. THE MASTISOL CAUSE AN ALLERGIC REACTION OF SEVERE BLISTERING AND ITCHING. IT WAS SO PAINFUL. I HAVE HEARD THIS NOW FROM MANY PEOPLE WHO HAVE HAD ORTHOPEDIC SURGERY. MASTISOL IS NASTY STUFF, DIFFICULT TO REMOVE AND JUST UNNECESSARY. PLEASE WARN DOCTORS AND PTS OF THE POTENTIAL FOR AN ALLERGIC REACTION INCLUDING SEVERE BLISTERING AND POSSIBLE SKIN INFECTION. THANK YOU. HOW COULD I TEXT OR SEND A PHOTO?. DATES OF USE: (B)(6)2014. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED ? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476137 MASTISOL ADHESIVE GLUE KGX FERNDALE LABORATORIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention