BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERIGEL

    MDR report key: 5646238 · Received May 7, 2016

    Report

    Report Number
    MW5062165
    Event Type
    Injury
    Date Received
    May 7, 2016
    Date of Event
    June 12, 2014
    Report Date
    May 7, 2016
    Manufacturer
    AMERX HEALTH CARE CORP
    Product Code
    MGQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS PRESCRIBED THIS MED FOR A TOE ULCER. MY LEG STARTED GETTING SWOLLEN AND RED. DOCTOR TOLD ME IT WAS NORMAL SWELLING. EVENTUALLY THE INFECTION TOOK OVER AND MY TOE GREW 4 TIMES ITS SIZE...HAD GANGRENE..LOST THE FRONT OF MY FOOT THANKS TO THIS STUFF NOT DOING ITS JOB. I WAS NEVER INFORMED ABOUT THE RECALL !!!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294413 AMERIGEL AMERIGEL MGQ AMERX HEALTH CARE CORP 3WD05

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other