BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 3122624 · Received May 15, 2013

    Report

    Report Number
    2246315-2013-00327
    Event Type
    Other
    Date Received
    May 15, 2013
    Report Date
    May 10, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    SWOLLEN KNEE [JOINT SWELLING]. KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A PHYSICIAN VIA OTHER NON-HEALTH PROFESSIONAL REGARDING A FEMALE PATIENT (AGE NOT PROVIDED), INITIALS UNKNOWN. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT INITIATED TREATMENT WITH SYNVISC ONE (HYLAN G-F 20) INJECTION; DOSAGE REGIMEN AND ROUTE NOT PROVIDED. THE LOT NUMBER OF SYNVISC ONE WAS NOT PROVIDED. ON AN UNSPECIFIED DATE OVER A YEAR AGO, SOME TIME AFTER THE INJECTION, THE PATIENT PRESENTED IN THE EMERGENCY DEPARTMENT WITH SWOLLEN KNEE. JOINT ASPIRATION WAS PERFORMED; AN UNSPECIFIED AMOUNT WAS ASPIRATED AND CULTURE TEST WAS PERFORMED. THE PATIENT WAS STARTED ON ANTIBIOTIC WHILE IN THE EMERGENCY DEPARTMENT. ON AN UNSPECIFIED DATE, THE CULTURE TEST WAS NEGATIVE AND THE ANTIBIOTIC WAS SUBSEQUENTLY STOPPED. ON AN UNSPECIFIED DATE, THE PATIENT RECEIVED STEROID INJECTION IN THE KNEE. THE ACTION TAKEN WITH SYNVISC ONE TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENTS OF SWOLLEN KNEE AND KNEE EFFUSION WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENTS OF SWOLLEN KNEE WAS SEVERE AND FOR KNEE EFFUSION WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE A CAUSAL RELATIONSHIP OF SYNVISC ONE WITH BOTH THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214584 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention