BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2823606 · Received November 2, 2012

    Report

    Report Number
    2246315-2012-00338
    Event Type
    Other
    Date Received
    November 2, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 16, 2012
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    PAIN IN KNEE [ARTHRALGIA]. HOW LONG IT WOULD TAKE FOR SYNVISC ONE TO KICK IN [DEVICE INEFFECTIVE]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012, FROM A PHYSICIAN REGARDING A FEMALE PT (AGE NOT PROVIDED), INITIALS UNK. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE IN (B)(6) 2012 (12 DAYS AGO), THE PT INITIATED TREATMENT WITH SYNVISC ONE (HYLAN G-F 20), DOSAGE REGIMEN NOT PROVIDED. THE LOT NUMBER FOR SYNVISC ONE WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT DEVELOPED SIGNIFICANT PAIN. IT WAS REPORTED THAT THE PHYSICIAN TRIED TO ASPIRATE PRIOR TO INJECTION, BUT THERE WAS NO EFFUSION TO WITHDRAW. THE ACTION TAKEN WITH SYNVISC ONE WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT OF PAIN WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF PAIN WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE RELATIONSHIP BETWEEN SYNVISC ONE AND THE EVENT OF PAIN. F/U INFO WAS RECEIVED ON (B)(6) 2012, FROM THE PHYSICIAN WHICH UPGRADED THE CASE TO SERIOUS (AS INTERVENTION WAS REQUIRED FOR THE EVENT OF PAIN IN KNEE). THE INFO RECEIVED, UPDATED THE PT'S DEMOGRAPHICS AND CLINICAL COURSE. THE PT'S INITIALS WERE (B)(6). ONE AND A HALF WEEK AFTER RECEIVING TREATMENT WITH SYNVISC ONE, THE PT EXPERIENCED DEVICE INEFFECTIVENESS ("HOW LONG IT WOULD TAKE FOR SYNVISC ONE TO KICK IN") AND COULD NOT STAND THE PAIN IN HER KNEE (PREVIOUSLY REPORTED AS PAIN). ON AN UNSPECIFIED DATE, THE PT RECEIVED TREATMENT WITH CORTISONE INJECTION FOR THE EVENT OF PAIN IN HER KNEE. IT WAS REPORTED THAT THERE WAS NOT AN ADVERSE EVENT WITH SYNVISC ONE AS IT HAD NOT HAD TIME TO WORK. THE REPORTER DID NOT PROVIDE THE RELATIONSHIP BETWEEN SYNVISC ONE AND THE EVENT OF "HOW LONG IT WOULD TAKE FOR SYNVISC TO KICK IN."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention