BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2094061 · Received April 29, 2011

    Report

    Report Number
    2246315-2011-00094
    Event Type
    Other
    Date Received
    April 29, 2011
    Date of Event
    January 1, 2009
    Report Date
    April 20, 2011
    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

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

    Description of Event or Problem · 1

    PAIN WITH THE INJECTION [INJECTION SITE PAIN]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011 FROM A (B)(6) OLD FEMALE PT, INITIALS S-S, WITH A HISTORY OF OSTEOARTHRITIS, WHO EXPERIENCED PAIN WITH INJECTION AND KNEE PAIN AFTER STARTING SYNVISC-ONE. THE PT RECEIVED ONE INJECTION OF SYNVISC-ONE INTO HER RIGHT KNEE IN 2009. THE PT REPORTED THAT SHE EXPERIENCED PAIN WITH THE INJECTION AND WORSENED KNEE PAIN (DATE NOT PROVIDED). THE PT REQUIRED TREATMENT FOR HER SYMPTOMS. THE PT REPORTED THAT SHE RECEIVED ONE INJECTION OF CORTISONE INTO HER RIGHT KNEE (DATE NOT PROVIDED). THE PRODUCT LOT NUMBER WAS NOT REPORTED. AT THE TIME OF THIS REPORT THE OUTCOME OF THE PT WAS UNK. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2011 IN THE FORM OF QA RESULTS. THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCHED RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention