BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTISOL LIQUID ADHESIVE

    MDR report key: 6136111 · Received November 28, 2016

    Report

    Report Number
    MW5066421
    Event Type
    Injury
    Date Received
    November 28, 2016
    Date of Event
    August 30, 2016
    Report Date
    October 23, 2016
    Manufacturer
    FERNDALE LABORATORIES, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SERIOUS ALLERGIC REACTION. WENT TO URGENT CARE AND BACK TO SURGEON TO CUT OFF CAST. DURING SURGERY FOR BILATERAL THUMB CARPOMETACARPAL (LEFT THUMB), MASTISOL LIQUID ADHESIVE WAS USED CAUSING HUGE BLISTERS AND RASH ON BOTH SIDES OF HAND AND ARM. HOW WAS IT TAKEN OR USED: SKIN. WHY WAS THE PERSON USING THE PRODUCT: SURGERY. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2016. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2016. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT: NO. DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN: DIDN'T RESTART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780908 MASTISOL LIQUID ADHESIVE MASTISOL LIQUID ADHESIVE KGX FERNDALE LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other LEVOTHYROXINE| LISINOPRIL| VITAMIN D3