BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 269760 · Received March 17, 2000

    Report

    Report Number
    2410673-2000-00001
    Event Type
    Injury
    Date Received
    March 17, 2000
    Date of Event
    June 1, 1999
    Report Date
    March 16, 2000
    Manufacturer
    FIDIA SPA
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM WYETH-AYERST LABORATORIES: PT REPORTED THAT THEY HAD INJECTIONS OF HYALGAN INTO THEIR RIGHT KNEE IN 1999. THEY HAD GOOD RESPONSE, BUT 3 MONTHS AFTER THE INJECTIONS WERE GIVEN THEY DEVELOPED PAIN AND GOUT IN THE KNEE, AS WELL AS INFLAMMATION. AN ARTHROSCOPY WAS DONE AND MORE ARTHRITIS WAS FOUND. THE CONSUMER WHO REPORTED THE ADVERSE EVENTS TO WYETH-AYERST CONTACTED THE CO ON 3/16/00 IN RESPONSE TO A REQUEST FOR ADD'L INFO. THEY REPORT THAT AT SOME TIME PRIOR TO RECEIVING HYALGAN THEIR PHYSICIAN HAD DRAINED FLUID FROM THE KNEE AND PT HAD RECEIVED A CORTISONE SHOT. PT HAD 5 HYALGAN INJECTIONS AND "FELT PRETTY GOOD FOR A WHILE" BUT "MAYBE A COUPLE OF MONTHS" AFTER THE LAST INJECTION "MY KNEE WENT HAYWIRE": PT DEVELOPED GOUT AND WAS HOSPITALIZED IN 6/99. AT THAT TIME "AN ORTHOPEDIC SURGEON PUT RODS IN MY KNEE TO SUCK EVERYTHING OUT." THE PT REPORTS THEY "JUST HAD A CORTISONE SHOT AND MY KNEE FEELS PRETTY GOOD." PT IS ALSO DOING PHYSICAL THERAPY EXERCISES. CORRECTIVE TREATMENT: CORTISONE, PHYSICAL THERAPY EXERCISES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization