BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 724615 · Received June 8, 2006

    Report

    Report Number
    2246315-2006-00048
    Event Type
    Injury
    Date Received
    June 8, 2006
    Date of Event
    January 13, 2006
    Report Date
    April 12, 2006
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REFERENCE NO.: SYNV-15895. ADDITIONAL INFO WAS RECEIVED ON 18-APR-2006 FROM A NURSE. THE NURSE CONFIRMED THAT THE PT DEVELOPED HIVES FOLLOWING HER THIRD SYNVISC INJECTION AND WAS TREATED BY ANOTHER PHYSICIAN WITH ORAL PREDNISONE. THE NURSE WAS UNSURE IF THE PT HAD MORE THAN ONE COURSE OF STEROID. THE OFFICE WAS IN CONTACT WITH THE PT LAST WEEK AND SHE WAS STILL COMPLAINING OF HIVES ON HER FACE. AT THE TIME OF THIS REPORT, THE PT HAD NOT YET RECOVERED. ADDITIONAL INFO WAS RECEIVED ON 08-MAY-2006 FROM THE PT'S ORTHOPEDIST. THE PT WAS A 60-YEAR-OLD FEMALE, INITIALS KDP, WHO HAD A ONE TO TWO YEAR MEDICAL HISTORY OF MILD OSTEOARTHRITIS WITH JOINT NARROWING. THE PT HAD A PREVIOUS ARTHROSCOPY AS WELL AS PRIOR TREATMENT WITH NSAIDS AND STEROIDS. THE PT ALSO HAD A TEN YEAR HISTORY OF HIVES WHICH LAST LESS THAN A WEEK AND ALLERGIES TO SHELLFISH AND BEE STINGS. A RECENT FOOD ALLERGY WORK-UP WAS NEGATIVE. THE PHYSICIAN CONFIRMED THE SERIES OF THREE INJECTIONS OF SYNVISC INTO THE RIGHT KNEE. NO EFFUSION WAS COLLECTED PRIOR TO THE INJECTIONS. ON 13-JAN-2006, THE PT EXPERIENCED HIVES, ITCHING, FACIAL SWELLING AND SWOLLEN EYES, AS WELL AS RIGHT KNEE SWELLING WHICH LASTED APPROC ONE DAY. IN JANUARY 2006, THE PT WAS TREATED WITH PREDNISONE, ALLEGRA, VISTARIL AND MULTIPLE LOTIONS FOR THE HIVES, FACIAL SWELLING AND ITCHING. THE PHYSICIAN REPORTED THAT ONLY PREDNISONE HELPED AND THAT IS ALL THAT THE PT CONTINUED TO TAKE. ON 26-APR-2006, THE PT EXPERIENCED SHORTNESS OF BREATH AND WENT TO THE EMERGENCY ROOM, WHERE SHE RECEIVED NEBULIZER TREATMENT AND PREDNISONE, 60 MG. AT THE TIME OF THIS REPORT, THE HIVES, ITCHING, FACIAL SWELLING AND SWOLLEN EYES HAD NOT RESOLVED. THE PHYSICIAN ASSESSED THE RELATIONSHIP OF THE RIGHT KNEE SWELLING TO SYNVISC AS PROBABLE AND THE RELATIONSHIP OF THE HIVES, ITCHING, FACIAL SWELLING AND SWOLLEN EYES TO SYNVISC AS UNK. THE PHYSICIAN NOTED THAT THE PT HAD STATED THAT HER ALLERGIST, PRIMARY CARE PHYSICIAN AND ER PHYSICIAN ALL FELT THAT THE EVENTS WERE RELATED TO SYNVISC. MFR'S COMMENT: SYNOVIAL FLUID OR EFFUSION SHOULD BE REMOVED BEFORE EACH INJECTION OF SYNVISC.

    Description of Event or Problem · 1

    SHORTNESS OF BREATH, HIVES ALL OVER HER BODY, ITCHING ALL OVER HER BODY, SWOLLEN FACE, SWOLLEN EYES, RIGHT KNEE SWELLING. INFO WAS RECEIVED ON 12-APR-2006 FROM A PHYSICIAN VIA A NURSE REGARDING AN APPROC 59-YEAR-OLD FEMALE PT, INITIALS K-P, WITH A MEDICAL HISTORY OF OSTEOARTHRITIS, WHO EXPERIENCED HIVES WITH ITCHING ALL OVER HER BODY, SWOLLEN FACE AND SWOLLEN EYES. THE PT BEGAN TREATMENT WITH SYNVISC ON 28-DEC-2005. THE PT RECEIVED A SERIES OF THREE INJECTIONS OF SYNVISC INTO THE RIGHT KNEE ON 28-DEC-2005, 04-JAN-2006 AND 11-JAN-2006. THE PT EXPERIENCED HIVES WITH ITCHING ALL OVER HER BODY BEGINNING TWO DAYS AFTER THE THIRD INJECTION (13-JAN-2006). SHE WAS TREATED WITH PREDNISONE, WHICH HELPED FOR ABOUT 18 HOURS AND THEN THE HIVES AND ITCHING RETURNED. SHE TRIED OTHER ANTIHISTAMINES INCLUDING ALLEGRA AND NOTHING WORKED. ON 12-APR-2006, HER FACE AND EYES WERE SWOLLEN. THE PT HAD NOT TAKEN ANY OTHER MEDICATIONS DURING SYNVISC TREATMENT PERIOD OR AFTER, EXCEPT FOR TREATMENT OF THE REACTION. THE PT HAS NO KNOWN ALLERGY TO CHICKEN PRODUCTS BUT DOES HAVE AN ALLERGY TO ERYTHROMYCIN. AT THE TIME OF THIS REPORT, THE PT HAD NOT YET RECOVERED. THE PHYSICIAN ASSESSED THE RELATIONSHIP OF THE EVENTS TO SYNVISC AS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION NA U05051 & X0517

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R