BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLA G-F 20) INJECTION

    MDR report key: 3313756 · Received August 21, 2013

    Report

    Report Number
    2246315-2013-00431
    Event Type
    Other
    Date Received
    August 21, 2013
    Date of Event
    July 1, 2013
    Report Date
    August 12, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2013. EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT #V1211, WITH EXPIRATION DATE (08/2015) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    KNEE WAS WARM [JOINT WARMTH]. KNEE WAS SWOLLEN [JOINT SWELLING]. KNEE WAS PAINFUL [ARTHRALGIA]. KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A NON-HEALTH PROFESSIONAL VIA SALES REPRESENTATIVE REGARDING A (B)(6) OLD FEMALE PT, INITIAL (B)(6). THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT INITIATED TREATMENT WITH SYNVISC (HYLAN GF-20) INJECTION INTO AN UNSPECIFIED KNEE (ROUTE OF ADMINISTRATION AND DOSAGE REGIMEN NOT PROVIDED). THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON (B)(6) 2013, THE PT RECEIVED SECOND INJECTION OF THE THREE INJECTION SERIES. ON (B)(6) 2013, THE PT DESCRIBED THE KNEE AS WARM, SWOLLEN AND PAINFUL. ON AN UNSPECIFIED DATE OF (B)(6) 2013, THE PT DEVELOPED KNEE EFFUSION AND 10 ML OF FLUID WAS ASPIRATED FROM THE KNEE. THE PT RECEIVED TREATMENT WITH 1.5 ML OF STEROID INJECTION POST-ASPIRATION. IT WAS REPORTED THAT THE PT HAD NO STEROID INJECTED PRIOR TO THE SYNVISC INJECTION. THE OUTCOME FOR ALL THE EVENTS WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SYNVISC AND ALL THE EVENTS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406217 SYNVISC (HYLA G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK V1211

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention