BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 1454783 · Received August 12, 2009

    Report

    Report Number
    2410673-2009-00005
    Event Type
    Injury
    Date Received
    August 12, 2009
    Report Date
    August 12, 2009
    Manufacturer
    FIDIA SPA
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    INITIAL INFO RECEIVED FROM A CONSUMER BY (B)(4) ON 09-JUN-2009: A PT WAS INJECTED WITH HYALURONATE SODIUM [HYALGAN] FOR MILD ARTHRITIS OF THE RIGHT KNEE AND THEIR ENTIRE RIGHT LEG SWELLED. THE PT HAD INCREDIBLE PAIN AND THE INJECTION DISABLED THE PT. A PLASTIC BAG WAS FILLED WITH ICE CUBES AND APPLIED ON THE SWOLLEN KNEE CAP. DOCTORS INSISTED THAT THIS CAUSED DAMAGE TO THE TISSUE AND THE RESULT WAS AN INFECTED KNEE. THE PT'S DOCTORS STATED IT WAS AN ALLERGIC REACTION. THE PT'S LEG WAS SWELLING AND FLUSHED AS THE DAY PROGRESSED. THE PT WORE A COMPRESSION STOCKING WHICH HELPED. RELEVANT TESTS INCLUDED AN UNSPECIFIED ULTRASOUND WHICH SHOWED NO INDICATION THAT THERE WAS A VASCULAR PROBLEM. AT THE TIME OF THE REPORT, THE PT REPORTED HE WOULD BE PROCEEDING WITH THE ADDITIONAL FIVE SHOTS AND THERE WAS SOMEWHAT OF AN IMPROVEMENT, BUT THE PAIN WHICH THE PT WENT THROUGH DID NOT WARRANT ANOTHER TRY WITH THE INJECTIONS. NO FURTHER RELEVANT INFO REPORTED. ADDITIONAL INFO FOR HYALURONATE SODIUM [HYALGAN] FROM PRODUCT TECHNICAL COMPLAINT REPORT CASE (B)(4) DATED 14-JUL-2009, RECEIVED BY (B)(6) ON 15-JUL-2009: NO BATCH NUMBER WAS REPORTED, AND NO COMPLAINT SAMPLE WAS RECEIVED. CONCLUSION: NO INVESTIGATION/NO ASSESMENT POSSIBLE. WORE A COMPRESSION STOCKING WHICH HELPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYALGAN INTRA-ARTICULAR INJECTION MOZ FIDIA SPA NI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability