BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 3913016 · Received June 11, 2014

    Report

    Report Number
    2246315-2014-73335
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 2, 2014
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIVE TREATMENT: CORTISONE. OUTCOME: UNK. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME. SERIOUSNESS CRITERIA: INTERVENTION REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(4) 2014 FROM A CONSUMER. THIS CASE CONCERNS A PATIENT (NO DEMOGRAPHICS PROVIDED) WHOSE KNEES SWELLED TO TWICE THEIR NORMAL SIZE AND HAD A LOT OF WATER ON BOTH KNEES AFTER RECEIVING TREATMENT WITH SYNVISC. RELEVANT PAST DRUG INCLUDED SYNVISC (HAD INJECTIONS ABOUT 4-5 TIMES OVER THE PAST 5 YEARS, WITH MIXED SUCCESS). NO RELEVANT PAST MEDICAL HISTORY, CONCURRENT CONDITIONS AND CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNKNOWN DATE IN (B)(6) 2014, THE PATIENT'S INITIATED TREATMENT WITH SYNVISC INJECTION (ROUTE OF ADMINISTRATION, DOSAGE REGIMEN, FREQUENCY, LOT/BATCH NUMBER AND EXPIRATION DATE UNKNOWN) FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE,A FEW DAYS LATER, PATIENT'S KNEES SWELLED TO TWICE THEIR NORMAL SIZE AND THERE WAS A LOT OF WATER ON BOTH THE KNEES. THE PATIENT WENT BACK TO HER PHYSICIAN AND HE GAVE HIM AN INJECTION OF CORTISONE WHICH EVENTUALLY BROUGHT DOWN THE SWELLING. THE PATIENT'S KNEE WAS NOT DRAIN AS THE PHYSICIAN DID NOT WANT TO DRAIN OUT THE SYNVISC. ACTION TAKEN: UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344046 SYNVISC INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SYNVISC(PREV.)| CON MEDS= UNK