BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA INJ 10MG/ML

    MDR report key: 8191500 · Received December 20, 2018

    Report

    Report Number
    MW5082510
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    December 12, 2018
    Report Date
    December 12, 2018
    Manufacturer
    FERRING PHARMACEUTICALS INC.
    Product Code
    MOZ
    UDI-DI
    55566410001
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT NOTICED THAT HER KNEE WAS HAVING MORE PAIN WHILE SHE WAS WALKING IN (B)(6) IN BELOW 0 TEMPERATURES. SHE WAS CURIOUS IF THERE WAS ANY INFO IN TERMS OF THE MEDICATION REACTING POORLY IN COLDER TEMPERATURES. TOLD PT THAT THERE ISN'T ANY INFO THAT I'M AWARE OF WHICH WOULD INDICATE ONE WAY OR ANOTHER BUT THAT ARTHRALGIA IN GENERAL IS A POTENTIAL SIDE EFFECT OF THE MEDICATION. SHE SAID SHE ONLY EXPERIENCED IT IN THE COLD WEATHER. PT HAD MENTIONED IT TO HER PROVIDER WHO WASN'T AWARE IF THERE WAS ANY EFFECT EITHER. DATES OF USE: (B)(6) 2017 - PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027570 EUFLEXXA INJ 10MG/ML ACID, HYALURONIC, INTRAARTICULAR MOZ FERRING PHARMACEUTICALS INC. 55566410001

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR