BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1063067 · Received June 19, 2008

    Report

    Report Number
    2246315-2008-00089
    Event Type
    Other
    Date Received
    June 19, 2008
    Date of Event
    May 17, 2008
    Report Date
    May 22, 2008
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). WORSENING KNEE SWELLING [JOINT SWELLING], WORSENING KNEE PAIN [ARTHRALGIA], WORSENING KNEE REDNESS [ERYTHEMA], LEFT KNEE ASPIRATED [JOINT EFFUSION]. CASE DESCRIPTION: INITIAL INFO WAS RECEIVED ON 22-MAY-2008 FROM HCP VIA COMPANY REP REGARDING A (B) (6) FEMALE PT, (B) (6), WITH AN UNSPECIFIED MEDICAL HISTORY. THE PT RECEIVED AN INJECTION OF SYNVISC IN THE LEFT KNEE ON (B) (6) 2008. TWO DAYS AFTER RECEIVING THE INJECTION, SHE EXPERIENCED PROGRESSIVELY WORSENING KNEE PAIN, SWELLING, AND REDNESS. ON (B) (6) 2008, HCP REASSESSED THE PT'S SYMPTOMS AND DIAGNOSED HER WITH AN ADVERSE REACTION TO SYNVISC. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS UNK. NO FURTHER INFO PROVIDED. ADD'L INFO WAS RECEIVED ON 13-JUN-2008 FROM HCP. THE PT HAS A MEDICAL HISTORY OF MILD LEFT KNEE OSTEOARTHRITIS FOR DURATION OF (8) MONTHS WITH PREVIOUS NSAID THERAPY. HCP PROVIDED SYNVISC LOT# V07251. EFFUSION WAS NOT COLLECTED PRIOR TO SYNVISC INJECTION ON (B) (6) 2008. ON (B) (6) 2008, THE PT EXPERIENCED WORSENING KNEE PAIN, SWELLING, AND REDNESS. ON 21-MAY-2008, 30 CC OF JOINT FLUID WERE REMOVED FROM THE PT'S LEFT KNEE AND THE PT RECEIVED A 1 CC INJECTION OF DEPO-MEDROL 80 MG/ML. ALL THE EVENTS ABATED BY (B) (6) 2008. HCP CAUSALITY ASSESSMENT FOR THE RELATIONSHIP OF THE EXPERIENCED EVENTS TO SYNVISC WAS DEFINITELY RELATED. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS RECOVERED. NO FURTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION UNK V07251

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention