BEUDAMED
    FDA Adverse Event Other Summary report: N

    EUFLEXXA

    MDR report key: 1340328 · Received February 18, 2009

    Report

    Report Number
    2244564-2009-00012
    Event Type
    Other
    Date Received
    February 18, 2009
    Date of Event
    February 3, 2009
    Report Date
    February 12, 2009
    Manufacturer
    BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
    Product Code
    MOZ
    PMA / PMN Number
    P010029
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS: POSSIBLE, BASED ON THE INFORMATION OBTAINED AT THE TIME OF THIS REPORT. FURTHER INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER REPORTS: A (B)(6) MALE RECEIVED EUFLEXXA (1% SODIUM HYALURONATE) FOR DEGENERATIVE JOINT DISEASE AND EXPERIENCED WORSENING PAIN AND SWELLING IN HIS RIGHT KNEE. THE PT RECEIVED 2 INJECTIONS IN THE RIGHT KNEE OF EUFLEXXA (1% SODIUM HYALURONATE), ADMINISTERED ONE WEEK APART. THE FIRST INJECTION WAS ADMINISTERED ON (B)(6) 2009; THE SECOND INJECTION WAS ADMINISTERED ON (B)(6) 2009. ON (B)(6) 2009, THE PT DEVELOPED PAIN AND SWELLING IN HIS RIGHT KNEE. ON (B)(6) 2009, THE PAIN AND SWELLING WORSENED AND THE PT WENT TO THE EMERGENCY ROOM (ER). THE PT REPORTED TO HIS ORTHOPEDIC PHYSICIAN THAT THE ER STAFF ASPIRATED 70CC FLUID FROM THE RIGHT KNEE AND ADMITTED THE PT TO THE HOSPITAL ON THE SAME DAY. ON (B)(6) 2009, THE PT UNDERWENT SURGERY TO FLUSH HIS RIGHT KNEE AND WAS ADMINISTERED ANTIBIOTICS (NAME, DOSE UNSPECIFIED). ON (B)(6) 2009, THE PT WAS DISCHARGED HOME FROM THE HOSPITAL ON THE ANTIBIOTIC KEFLEX (CEPHALEXIN) AND AN ANTI-INFLAMMATORY MEDICATION (NAME, DOSE UNSPECIFIED). ON (B)(6) 2009, THE PT WAS SEEN BY HIS ORTHOPEDIC PHYSICIAN AND THE PAIN AND SWELLING HAD WORSENED, THE PT'S ORTHOPEDIC PHYSICIAN RECOMMENDED THAT THE PT RETURN TO THE ER. AT THE TIME OF THIS REPORT, THE STATUS OF THE EVENTS ARE UNK. CONCOMITANT MEDICATION INCLUDED: LASIX (FUROSEMIDE) DOSE AND INDICATION UNSPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EUFLEXXA 1% SODIUM HYALURONATE MOZ BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. RC0080A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization LASIX (DATES UNSEPCIFIED)