BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPARTZ 25MG/2.5ML SYRINGE

    MDR report key: 1852936 · Received September 29, 2010

    Report

    Report Number
    MW5017648
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    May 20, 2009
    Report Date
    September 14, 2010
    Manufacturer
    SMITH & NEPHEW
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER SECOND SHOT OF SUPARTZ, PAIN STARTED IN RIGHT KNEE ON THIRD SHOT. DOCTOR WAITED TWO DAYS TO GIVE SHOT. SUPARTZ WAS GIVING FOR TEN WEEKS. ONE SHOT IN RIGHT, ONE SHOT THE FOLLOWING WEEK IN LEFT KNEE. BY THE TIME ALL SHOTS IN KNEES WERE GIVEN, I TOLD DOCTOR MY KNEES WERE WORSE. I COULD BARELY WALK BECAUSE OF PAIN. TODAY I AM USING A CANE, A WALKER, AND HAD TO BE PUT ON PAIN MEDICATION. HE ALSO SAID HE COULD NOT DO ANY MORE FOR ME AND DISCHARGED ME. DOSE OR AMOUNT: 25MG/2.5ML SYRINGE. FREQUENCY: 10 SHOTS. ROUTE: 10 WEEKS. DATES OF USE: (B)(6) 2009 - (B)(6) 2009, (B)(6) 2009, (B)(6) 2009, (B)(6) 2009, (B)(6) 2009, (B)(6) 2009, (B)(6) 2009. DIAGNOSIS OR REASON FOR USE: ARTHRITIS MODERATE IN KNEES. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES. EVENT REAPPEARED AFTER REINTRODUCTION?: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPARTZ 25MG/2.5ML SYRINGE SUPARTZ SODIUM HYALURONATE MOZ SMITH & NEPHEW

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability