BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 2123433 · Received October 29, 2008

    Report

    Report Number
    2244564-2008-00152
    Event Type
    Injury
    Date Received
    October 29, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 30, 2008
    Product Code
    MOZ
    PMA / PMN Number
    P010029
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A SPONTANEOUS A CASE REPORT FROM A PHYSICIAN. THE PHYSICIAN REPORTED THAT THE PT EXPERIENCED AN INCREASED HEART RATE AFTER THE THIRD INJECTION OF EUFLEXXA. THE PT WAS HOSPITALIZED AND HAD A CORONARY ARTERIAL STENT PLACED. REPORTER CAUSALITY: THE PHYSICIAN STATED THAT HE WAS UNSURE IF THE EUFLEXXA CAUSED THE INCREASED HEART RATE. COMPANY CAUSALITY: IT WAS DETERMINED THAT THE EVENTS IN THIS REPORT WERE UNLABELED AND NOT RELATED TO THE USE OF EUFLEXXA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EUFLEXXA 1% SODIUM HYALURATE MOZ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R