BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 6562782 · Received May 11, 2017

    Report

    Report Number
    MW5069710
    Event Type
    Injury
    Date Received
    May 11, 2017
    Date of Event
    January 1, 2016
    Report Date
    May 10, 2017
    Manufacturer
    FERRING
    Product Code
    MOZ
    UDI-DI
    55566410001
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT STATED NO REACTION OR ADVERSE EFFECT TO EUFLEXXA. HOWEVER, WHILE UPDATING MEDICAL HISTORY PT REPORTED THAT SHE HAD A RECENT SURGERY FOR SOMETHING FOUND IN HER COLONOSCOPY. THE SURGERY FOUND A TUMOR THAT WILL BE CHECKED AGAIN LATER THIS YEAR AND MAY NEED TO BE TREATED WITH ORAL CHEMO. WHILE IN THE HOSPITAL THEY FOUND A HEART MURMOR. DOSE OR AMOUNT: 10MG, FREQUENCY: UTD, ROUTE: SC. DATES OF USE: (B)(6) 2013 - ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341309 EUFLEXXA ACID HYALURONIC INTRAARTICULAR MOZ FERRING L17762A 55566410001

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization CRESTOR | ESTRADIOL| NEXIUM | OMEGA3| VALTREX| VITAMIN C| WELCHOL