BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2350861 · Received November 22, 2011

    Report

    Report Number
    2246315-2011-00291
    Event Type
    Other
    Date Received
    November 22, 2011
    Date of Event
    October 1, 2011
    Report Date
    November 15, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011 FROM A (B)(6) YEAR OLD FEMALE PATIENT, INITIALS (B)(6) WITH OSTEOARTHRITIS. THE PATIENT'S MEDICAL HISTORY INCLUDED PHLEBITIS. ON (B)(6) 2011, THE PATIENT INITIATED SYNVISC-ONE (HYLAN G-F 20) 6 ML INJECTION ONCE IN THE LEFT KNEE. THE PRODUCT LOT NUMBER WAS NOT REPORTED. ONE WEEK AFTER RECEIVING THE INJECTION, SHE BEGAN EXPERIENCING INCREASED SWELLING, PAIN, DIFFICULTY IN WALKING AND CALF PAIN. THE X RAY OF THE LEFT KNEE AND DOPPLER OF THE CALF WERE PERFORMED ON THE ADVICE OF HER FAMILY PRACTITIONER, AS THE PATIENT HAD A HISTORY OF PHLEBITIS. THE RESULTS WERE NEGATIVE. SHE HAD BEEN ON BEDREST, USING ICE AND HEAT. SHE COULD NOT BEND THE KNEES ALSO. ON (B)(6) 2011, SHE VISITED HER ORTHOPEDIC HEALTH CARE PROFESSIONAL AND APPROXIMATELY 50 CC OF THE FLUID WAS DRAINED FROM THE KNEE AND SHE WAS GIVEN AN INJECTION OF DEPO MEDROL (METHYLPREDNISOLONE ACETATE). ALL LABS PERFORMED ON THE FLUID WERE NEGATIVE. BY (B)(6) 2011, HER KNEE ALMOST RETURNED TO NORMAL. NO ACTION WAS TAKEN WITH SYNVISC-ONE. THE OUTCOME OF THE EVENT OF CALF PAIN AND DIFFICULTY WALKING WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED.

    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 69 YR Required Intervention