BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION 2ML

    MDR report key: 1002321 · Received February 22, 2008

    Report

    Report Number
    2246315-2008-00023
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    December 1, 2007
    Report Date
    December 10, 2007
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLOOD CLOT IN RIGHT LEG [THROMBOSIS]. PAIN IN ANKLE [ARTHRALGIA]. PAIN IN RIGHT CALF [PAIN IN EXTREMITY]. SWELLING IN ANKLE/SWELLING IN RIGHT CALF (PERIPHERAL OEDEMA) [OEDEMA PERIPHERAL]. PAIN IN KNEE CAP [ARTHRALGIA]. SYNVISC HAS NOT WORKED AT ALL [DEVICE INEFFECTIVE]. CASE DESCRIPTION: PAIN IN ANKLE; SWELLING IN ANKLE/SWELLING IN RIGHT CALF; PAIN IN RIGHT CALF; PAIN IN KNEE CAP. INFO WAS RECEIVED ON 10-DEC-2007 FROM A MALE PT WHO HAD A MEDICAL HISTORY OF ARTHRITIS. THE PT RECEIVED A SERIES OF SYNVISC INJECTIONS IN BOTH KNEES ON THE FOLLOWING DATES: TWO TIMES IN THE SAME MONTH, AND THE FOLLOWING MONTH IN 2007. STARTING ON THREE DAYS LATER, HE EXPERIENCED PAIN AND SWELLING IN HIS RIGHT CALF AND ANKLE. HE ALSO EXPERIENCED PAIN IN HIS KNEE CAP. AT THE TIME OF THIS REPORT, THE PT HAD NOT YET RECOVERED. ADD'L INFO WAS RECEIVED ON 13-FEB-2008 FROM THE PT. HE REPORTED THAT ON 12-DEC-2007, HE WAS HOSPITALIZED FOR 9 DAYS DUE TO A BLOOD CLOT IN HIS RIGHT LEG, WHICH WAS THE SAME LEG THAT HE PREVIOUSLY REPORTED HAVING A SWOLLEN CALF. HE STATED THAT THE SYNVISC DID NOT WORK AT ALL, AS HIS PAIN WAS STILL THE SAME AS IT WAS BEFORE HE RECEIVED THE INJECTIONS. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT OUTCOME WAS NOT YET RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F 20) INJECTION 2ML INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization