BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 2771552 · Received September 14, 2012

    Report

    Report Number
    MW5027092
    Event Type
    Injury
    Date Received
    September 14, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 14, 2012
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER CALLED ON BEHALF OF HIS COUSIN REGARDING AN ADVERSE REACTION TO AN EUFLEX INJECTION. HE SAID SHE HAS BAD KNEES, AND WAS GIVEN A CORTISONE SHOT BY AN ORTHOPEDIC PHYSICIAN. REPORTER SAID THE CORTISONE DID NOT HELP THE PT, SO ABOUT TWO MONTHS LATER, ON (B)(6); THE PT RECEIVED AN EUFLEX INJECTION TO HELP WITH PAIN AND GIVE CUSHION TO THE KNEE JOINTS. ON (B)(6), THE PT WAS EXTREMELY OUT OF IT, DIDN'T RECOGNIZE THE REPORTER OR NURSING HOME STAFF, WAS BABBLING, AND COMPLAINED OF A HEADACHE. THE REPORTER SAID EVEN THE NURSING HOME AIDS, WHERE THE PT LIVED, WERE CONCERNED ABOUT HER BEHAVIOR. THE REPORTER BELIEVES EUFLEX CAUSED THESE ADVERSE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE MOZ

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR EUFLEX INJECTION