BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 235080 · Received March 26, 1999

    Report

    Report Number
    MW1016934
    Event Type
    Injury
    Date Received
    March 26, 1999
    Date of Event
    July 9, 1998
    Report Date
    March 26, 1999
    Manufacturer
    FIDIA PHARMACEUTICAL CORP.
    Product Code
    LZX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT IS AN 80-YEAR-OLD FEMALE WHO HAS VALGUS ARTHRITIS OF PREDOMINANTLY THE RIGHT KNEE. SHE UNDERWENT HYALGAN INJECTIONS AFTER CORTISONE INJECTIONS HAD FAILED. AFTER EACH INJECTION, SHE WOULD HAVE SWELLING IN HER LOWER LEGS. INITIALLY, THE REPORTER THOUGHT THIS WAS RELATED TO MILD CONGESTIVE HEART FAILURE AND FLUID RETENTION PROBLEMS OF HER HEALTH STATUS. HOWEVER, AFTER THE FIFTH INJECTION, SHE HAD TOTAL BODY EDEMA, IN HER HANDS, ARMS, SHOULDERS, LEGS, EVEN SOME PULMONARY EDEMA. IT WAS FELT THAT THIS WAS A MILD ANAPHYLACTOID REACTION TO THE HYALGAN. SHE WAS PLACED ON STEROIDS AND, OF COURSE, THE HYALGAN WAS DISCONTINUED AFTER THE FIFTH DOSE, AND THIS RESOLVED. SHE SEEMS TO HAVE FULLY RECOVERED FROM THIS, BUT IT APPEARS TO BE A SIGNIFICANT ALLERGIC REACTION TO HYALGAN. FOLLOW-UP LETTER REC'D FROM THE REPORTER ON 22 JAN 1999: "FLARE-UP OF RIGHT KNEE PAIN AFTER EACH OF THE 5 WEEKLY INJECTIONS OF HYALGAN. AFTER 5TH INJECTION, SWELLING [OF] ENTIRE BODY, PULMONARY EDEMA; [PT] HAD TO RECEIVE DIURETICS AND STEROIDS." EDITORIAL COMMENT: THE REPORTER CONSIDERED THE EVENT SERIOUS (REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE). ACCORDINGLY, CASE IS CONSIDERED SERIOUS FROM 22 JAN 1999. CORRECTIVE TREATMENT: DIURETICS AND STEROIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYALGAN INTRA-ARTICULAR INJECTION LZX FIDIA PHARMACEUTICAL CORP. NI NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention 4. TRISOPT, DATES: NI.| 2. LASIX, DATES: NI,| 3. ZESTRIL, DATES: NI,| 1. CARDURA, DATES: NI,