BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 3247620 · Received July 22, 2013

    Report

    Report Number
    2246315-2013-00408
    Event Type
    Other
    Date Received
    July 22, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 12, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WAS REC'D ON (B)(4) 2013. EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT V1201A, EXPIRY DATE (2015-07) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCE WERE NOTED. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC ONE IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    SWOLLEN KNEE/BLEW UP [JOINT SWELLING]. KNEE EFFUSION [JOINT EFFUSION]. TEMPERATURE WAS 104 [PYREXIA]. RED KNEE [ERYTHEMA]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS REC'D ON (B)(6) 2013 FROM A PHYSICIAN ASSISTANT REGARDING A FEMALE PT (AGE NOT PROVIDED), INITIALS (B)(6). THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS ADMINISTRATION OF THREE SERIES OF SYNVISC. ON (B)(6) 2013 (AT 2 PM), THE PT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE (HYLAN G-F 20) INJECTION, (DOSAGE REGIMEN NOT PROVIDED) INTO AN UNSPECIFIED KNEE AND WAS REPORTED TO BE FINE AFTER THE INJECTION. FOUR HOURS LATER (AT 6 PM), PT WENT TO THE EMERGENCY ROOM (ER), AS PT'S KNEE BLEW UP, WAS SWOLLEN AND TEMPERATURE WAS 104. THE COMPANY ASSESSED THE EVENT OF TEMPERATURE WAS 104 AS MEDICALLY SIGNIFICANT. IN THE ER, PT'S KNEE WAS ASPIRATED (KNEE EFFUSION). IT WAS REPORTED THAT THERE WAS NO INFECTION AND THE FLUID WAS TESTED FOR CRYSTALS. THE ACTION TAKEN WITH SYNVISC-ONE TREATMENT WAS NOT PROVIDED. THE OUTCOME OF THE EVENTS WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENTS WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE A CAUSAL RELATIONSHIPS BETWEEN SYNVISC-ONE AND THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341385 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK V1201A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R