BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 20169124 · Received September 6, 2024

    Report

    Report Number
    MW5159305
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 23, 2024
    Report Date
    September 3, 2024
    Manufacturer
    FERRING PHARMACEUTICALS INC.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED 3 EUFLEXXA INJECTIONS, WITH THE FIRST ONE I HAD A RED RASH ON MY LEG. I TOLD THE PA BEFORE THE SECOND INJECTION, AND SHE SAID THAT WAS ONE OF THE SIDES EFFECTS AND CONTINUED WITH THE SHOT. IN THE DAYS FOLLOWING I HAD SMALL RED SORES OPEN UP ON THE LEG. WENT BACK FOR 3RD INJECTION AND WAS TOLD AGAIN THIS IS NOT A SIDE EFFECT SO SHE CONTINUED WITH THE INJECTION. BY THE NEXT DAY MT LEGS WERE BREAKING OUT IN RED OPEN SORES, I HAD OPEN MOUTH SORES AND OPEN SORES ALL OVER MY HEAD. MY HAIR STARTED COMING OUT IN CLUMPS. I WENT TO MY PCP WHO PUT ME ON HIGH DOSES OF STEROIDS AND BENADRYL FOR THE LAST 2 WEEKS. THE HEAD SORES AND THE SKIN BRUISING CONTINUE. I AM SCHEDULED TO SEE HEMATOLOGIST FOR IMMUNOLOGICAL REACTION ON SEPTEMBER 9TH. REF REPORTS: MW5159303, MW5159304.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297587 EUFLEXXA ACID, HYALURONIC, INTRAARTICULAR MOZ FERRING PHARMACEUTICALS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| O AMBIEN 5 MG DAY AS NEEDED| BENADRYL| PHENTRAMINE| PREDNISONE 10MG DAY| TRAMADOL 50MG AS NEEDED