BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3108897 · Received May 3, 2013

    Report

    Report Number
    2246315-2013-00309
    Event Type
    Other
    Date Received
    May 3, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 25, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY WAS RECEIVED ON (B)(4) 2013. EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER S1221, WITH EXPIRATION DATE (2015-05) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    PAIN; SWELLING; JOINT EFFUSION. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A PHYSICIAN REGARDING A (B)(6) MALE PATIENT, INITIALS UNKNOWN. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2013, THE PATIENT INITIATED TREATMENT WITH SYNVISC (HYLAN GF 20) INJECTION, DOSAGE REGIMEN NOT PROVIDED, IN AN UNSPECIFIED LOCATION. ON AN UNSPECIFIED DATE IN 2013, THE PATIENT DEVELOPED PAIN AND SWELLING WHICH CONTINUED THROUGHOUT THE WEEKEND. ON (B)(6) 2013, 30 CC OF CLOUDY YELLOW SYNOVIAL FLUID (JOINT EFFUSION) WAS ASPIRATED BY THE PHYSICIAN AND AN INTRA-ARTICULAR CORTICOSTEROID (UNSPECIFIED) INJECTION WAS ADMINISTERED FOR PAIN SWELLING AND JOINT EFFUSION. THE TREATMENT WITH SYNVISC WAS PERMANENTLY DISCONTINUED. THE OUTCOME FOR THE EVENTS OF PAIN, SWELLING AND JOINT EFFUSION WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE THE CAUSAL RELATIONSHIP BETWEEN SYNVISC AND ALL THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193644 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK S1221

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention