BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 2223126 · Received August 16, 2011

    Report

    Report Number
    2244564-2011-00105
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BIO-TECHNOLOGY GENERAL (ISRAEL) LTD
    Product Code
    MOZ
    PMA / PMN Number
    P010029
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY CAUSALITY: POSSIBLE, BASED ON THE INFO PROVIDED AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS SERIOUS DEVICE REPORT WAS FROM A PHYSICIAN VIA A MEDICAL SECRETARY VIA A SALES REP IN THE US. THE PT, A FEMALE OF UNK RACE AND AGE, RECEIVED HER FIRST EUFLEXXA (1% SODIUM HYALURONATE) FOR AN UNK INDICATION AND EXPERIENCED INFECTION, PAIN, CRYSTALLINE URIC ACID, CRYSTALLINE CALCIUM AND (B)(6). ON AN UNK DATE, THE PT RECEIVED EUFLEXXA. THE PT WAS HOSPITALIZED WITH INFECTION AND PAIN. DEBRIDEMENT WAS PLANNED FOR (B)(6) 2011. THE MEDICAL SECRETARY REPORTED SHE THOUGHT IT MIGHT BE A BAD BATCH OF SOMETHING WITH THE MEDICATION (EUFLEXXA). ON AN UNK DATE, THE PT WAS TRANSFERRED TO ANOTHER HOSP. ON UNK DATES, FLUID WAS DRAWN FROM THE KNEE THREE TIMES. THE FIRST FLUID SPECIMEN CONTAINED CRYSTALLINE URIC ACID. THE SECOND FLUID SPECIMEN CONTAINED CRYSTALLINE CALCIUM. THE THIRD SPECIMEN SHOWED (B)(6). THE PHYSICIAN REPORTED HE DID NOT BELIEVE IT WAS (B)(6). THE PT'S CASE WAS TRANSFERRED TO AN INFECTIOUS DISEASE PHYSICIAN. NO OTHER DETAILS WERE AVAILABLE. NO CONCOMITANT MEDICATIONS WERE REPORTED. NO MEDICAL HISTORY WAS REPORTED. FURTHER INFO WAS REQUESTED. IF NEW SIGNIFICANT INFO IS RECEIVED, THE CASE WILL BE RE-SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EUFLEXXA 1% SODIUM HYALURONATE MOZ BIO-TECHNOLOGY GENERAL (ISRAEL) LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization