BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC ONE

    MDR report key: 3516563 · Received November 22, 2013

    Report

    Report Number
    2246315-2013-20176
    Date Received
    November 22, 2013
    Date of Event
    January 1, 2013
    Report Date
    November 17, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE WAS RECEIVED FROM UNITED STATES ON (B)(6) 2013 FROM A PT. THIS CASE CONCERNS A PT (DEMOGRAPHICS UNSPECIFIED) WHO DEVELOPED AN ALLERGIC REACTION TO ONE OR MORE OF THE INJECTIONS' COMPONENTS, HAD CALF MUSCLES CRAMP AND DEVELOPED KNEE PAIN THAT WAS INCREASING IN SEVERITY/PAIN EXTENDED DOWN TO PT'S FOOT AND UP TO THE HIP/SEVERE UNREMITTING PAIN AFTER RECEIVING TREATMENT WITH SYNVISC ONE. NO MEDICAL HISTORY, PAST DRUGS, CONCURRENT CONDITIONS AND CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNSPECIFIED DATE IN 2013 (ABOUT 75 DAYS AGO), THE PT RECEIVED TREATMENT WITH SYNVISC ONE INJECTION (ROUTE OF ADMINISTRATION, DOSAGE REGIMEN, BATCH/LOT NUMBER AND EXPIRATION DATE: UNK) INTO BOTH KNEES FOR AN UNK INDICATION. ON AN UNSPECIFIED DATE IN 2013, THE PT DEVELOPED SEVERE, UNREMITTING KNEE PAIN EVER SINCE THE INJECTION. THE PAIN WAS INCREASING IN SEVERITY, SEEMINGLY AND IT WAS UNBEARABLE. THE PT REPORTED THAT PAIN EXTENDED DOWN TO FOOT UP TO THE LEG TO HIP. THE PT EXPERIENCED CALF MUSCLES CRAMP AS WELL. IT WAS REPORTED THAT PT'S LEFT LEG WAS WORSE THAN THE RIGHT. THE PT ASSUMED THAT THE ORTHOPEDIC SURGEON WHO ADMINISTERED THE INJECTIONS DID NOT PLACE THEM PROPERLY. IN ADDITION AN UNK DATE, THE PT SUFFERED FROM AN ALLERGIC REACTION TO ONE OR MORE OF THE INJECTIONS' COMPONENTS (UNSPECIFIED AT THE TIME OF REPORT). PT ALSO REPORTED THAT NO ORTHOPEDIC SURGEONS WERE ABLE TO HELP AS THEY SAID THAT THERE WAS NO RECOURSE, NO "ANTIDOTE" AND NO REMEDY. ACTION TAKEN: UNK. CORRECTIVE TREATMENT: NARCOTIC PAIN MEDICATION (UNSPECIFIED) FOR THE EVENT OF PAIN WAS INCREASING IN SEVERITY/PAIN EXTENDED DOWN TO PT FOOT AND UP TO THE HIP/SEVERE UNREMITTING PAIN." OUTCOME: UNK FOR THE EVENTS OF "ALLERGIC REACTION TO ONE OR MORE OF THE INJECTIONS' COMPONENTS" AND CALF MUSCLES CRAMP. AT THE TIME OF REPORT, THE EVENT OF "PAIN WAS INCREASING IN SEVERITY/PAIN EXTENDED DOWN TO PT'S FOOT AND UP TO THE HIP/SEVERE UNREMITTING PAIN" NOT YET RECOVERED. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND THE CONCLUSION WAS PENDING FOR THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609382 SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CON MEDS = UNK| PREV MEDS = UNK