BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 3913009 · Received June 11, 2014

    Report

    Report Number
    2246315-2014-76052
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 5, 2014
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUTCOME: NOT RECOVERED/NOT RESOLVED FOR ALL THE EVENTS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME. SERIOUSNESS CRITERIA: REQUIRED INTERVENTION FOR ALL EVENTS (BETAMETHASONE AND LIDOCAINE ADMINISTERED AS TREATMENT). NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(6) 2014 FROM A NON-HEALTHCARE PROFESSIONAL. THIS CASE IS CROSS REFERENCED WITH CASE (B)(4) (CLUSTER). THIS CASE INVOLVES A (B)(6) YEARS OLD MALE PATIENT WHO DEVELOPED LEFT KNEE PAIN, LEFT KNEE SWELLING AND LEFT KNEE EFFUSION WHILE RECEIVING TREATMENT WITH SYNVISC. THE PATIENT'S MEDICAL HISTORY , PAST DRUGS, CONCOMITANT MEDICATIONS OR CONCURRENT CONDITIONS WERE NOT REPORTED. ON 15(B)(6) 2014, THE PATIENT INITIATED TREATMENT WITH SYNVISC INJECTION AT A DOSE OF 2 ML, ONCE A WEEK FOR THREE WEEKS (ROUTE: UNK, BATCH/LOT NUMBER: (B)(4) AND EXPIRY DATE: 30-APR-2016) IN HIS LEFT KNEE FOR OSTEOARTHRITIS OF KNEE (ICD-9 CODE DIAGNOSIS OF 715.96). ON (B)(6) 2014, THE PATIENT DEVELOPED LEFT KNEE PAIN AND SWELLING. ON (B)(6) 2014, THE PATIENT CAME IN FOR HIS THIRD INJECTION OF SYNVISC IN HIS LEFT KNEE. THE PHYSICIAN'S LEFT KNEE, FOLLOWING WHICH PHYSICIAN ADMINISTERED THE THIRD INJECTION OF SYNVISC. THE PHYSICIAN ALSO INJECTED LCC BETAMETHASONE (CELESTONE) AND 1 CC LIDOCAINE INTO THE LEFT KNEE AS TREATMENT FOR THE PATIENT'S SYMPTOMS. ON (B)(6) 2014, THE PATIENT WAS SEEN BY THE PHYSICIAN AND WAS STILL EXPERIENCING SWELLING AND PAIN IN THE LEFT KNEE. THE PHYSICIAN AGAIN ASPIRATED 15 CC OF FLUID FROM THE PATIENT'S LEFT KNEE AND INJECTED 2 CC BETAMETHASONE AND 8 CC LIDOCAINE IN THE LEFT KNEE AS TREATMENT FOR HIS SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344105 SYNVISC INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) R13022

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention PREV MEDS= UNK| CON MEDS= UNK