BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 5393994 · Received January 20, 2016

    Report

    Report Number
    MW5059645
    Event Type
    Injury
    Date Received
    January 20, 2016
    Date of Event
    January 19, 2016
    Report Date
    January 20, 2016
    Manufacturer
    FERRING
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER MY 2ND AND 3RD EUFLEXXA INJECTIONS (THEY ARE GIVEN IN A SERIES OF 3 INJECTIONS, 1 WEEK APART), WITHIN A HALF-HOUR OF THE INJECTION, I BECAME SEVERELY OVERHEATED AND SWEATING ALL OVER MY BODY FOR A COUPLE OF HOURS. ABOUT AN HOUR OR SO AFTER THE INJECTION, MY HEART BEGAN TO RACE EXCESSIVELY AND CONTINUE TO DO SO FOR SEVERAL HOURS THEREAFTER. AFTER ABOUT 16 HOURS OR SO, THESE SYMPTOMS COMPLETELY RESOLVED THEMSELVES. DATES OF USE: (B)(6) 2016. REASON FOR USE: OSTEOARTHRITIS OF THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39955 EUFLEXXA INJECTION MOZ FERRING

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR