BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2971940 · Received February 19, 2013

    Report

    Report Number
    2246315-2013-00029
    Event Type
    Other
    Date Received
    February 19, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 12, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED IN THE FORM OF QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY ON (B)(4) 2013. EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT # P1204, WITH EXPIRATION DATE (2015-04) WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    PAIN IN LEFT KNEE [ARTHRALGIA]. SWELLING IN LEFT KNEE [JOINT SWELLING]. LEFT KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM ANOTHER HEALTH PROFESSIONAL VIA SALES REPRESENTATIVE REGARDING A (B)(6) MALE PATIENT, INITIALS (B)(6), WITH OSTEOARTHRITIS. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2013, THE PATIENT INITIATED TREATMENT WITH SYNVISC (HYLAN GF 20) INJECTION AT A DOSE OF 2 ML IN LEFT KNEE, FREQUENCY AND ROUTE OF ADMINISTRATION WAS NOT PROVIDED. ON (B)(6) 2013, THE PATIENT RECEIVED SECOND SYNVISC INJECTION. ON (B)(6) 2013, THE PATIENT PRESENTED WITH PAIN AND SWELLING IN THE LEFT KNEE AND UNKNOWN AMOUNT OF FLUID WAS ASPIRATED FROM THE LEFT KNEE AND CORTISONE WAS INJECTED INTO THE LEFT KNEE. THE SAME DAY, THE PATIENT WAS SCHEDULED FOR THIRD SYNVISC INJECTION WHICH WAS NOT GIVEN AT THAT TIME. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENTS OF PAIN IN LEFT KNEE, SWELLING IN LEFT KNEE AND LEFT KNEE EFFUSION WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE REPORTER DID NOT PROVIDE THE CAUSAL RELATIONSHIP BETWEEN SYNVISC AND ALL THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72198 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK P1204

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention