BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE

    MDR report key: 4142569 · Received September 30, 2014

    Report

    Report Number
    2246315-2014-32333
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 23, 2014
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(6) 2014 FROM A PATIENT. THIS CASE INVOLVES AN (B)(6) MALE PATIENT WHOSE HAD LEFT KNEE PAIN AFTER RECEIVING TREATMENT WITH SYNVISC ONE. IT WAS REPORTED THAT THE PATIENT HAD NOT ACHIEVED THE PAIN RELIEF HE WAS HOPING. NO MEDICAL HISTORY, PAST DRUG, CONCOMITANT MEDICATION OR CONCURRENT CONDITION WAS REPORTED. ON AN UNKNOWN DATE IN 2014 (THREE WEEKS AGO) , THE PATIENT COMMENCED TREATMENT WITH SYNVISC ONE INJECTION AT A DOSE OF 6 ML ONCE (ROUTE, BATCH/ LOT NUMBER AND EXPIRATION DATE: NOT PROVIDED) INTO BOTH KNEES (BILATERAL INJECTIONS) FOR OSTEOARTHRITIS. ON AN UNKNOWN DATE IN 2014, THE RIGHT KNEE WAS DOING WELL, BUT THE LEFT KNEE WAS CAUSING THE PATIENT A GREAT DEAL OF PAIN. IT WAS REPORTED THAT THE PATIENT HAD NOT ACHIEVED THE PAIN RELIEF HE WAS HOPING (SUBTHERAPEUTIC RESPONSE) . THE PATIENT RECEIVED A CORTISONE INJECTION AND THAT RELIEF WAS APPROXIMATELY 2 WEEKS. OUTCOME: UNKNOWN FOR LEFT KNEE PAIN. SERIOUSNESS CRITERIA: REQUIRED INTERVENTION FOR LEFT KNEE PAIN A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND PTC RESULTS WERE PENDING. REPORTER CAUSALITY: NOT REPORTED. COMPANY CAUSALITY: POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608017 SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention CON MEDS = UNKNOWN| PREV MEDS = UNKNOWN| CON MEDS =UNKNOWN| PREV MEDS =UNKNOWN