BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2223828 · Received August 18, 2011

    Report

    Report Number
    2246315-2011-00200
    Event Type
    Other
    Date Received
    August 18, 2011
    Date of Event
    June 10, 2011
    Report Date
    August 12, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT. EVAL SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPEC CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPEC 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.

    Description of Event or Problem · 1

    BACKACHE [RIGHT KNEE INJURY] [BACK PAIN]. PAIN BOTH HANDS [RIGHT KNEE INJURY] [PAIN IN EXTREMITY]. KNEE HOT TO THE TOUCH [RIGHT KNEE INJURY] [JOINT WARMTH]. RIGHT KNEE PAIN [RIGHT KNEE INJURY] [ARTHRALGIA]. RIGHT KNEE/ANKLE SWELLING [RIGHT KNEE INJURY] [JOINT SWELLING]. LOW GRADE FEVER [RIGHT KNEE INJURY] [PYREXIA]. CASE DESCRIPTION: A SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2011 FROM A CONSUMER REGARDING A (B)(6) FEMALE PT, INITIALS NOT PROVIDED, WITH A RIGHT KNEE INJURY. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2011, THE PT INITIATED SYNVISC-ONE, 6 ML INJECTION INTO THE RIGHT KNEE. ELEVEN DAYS AFTER RECEIVING THE SYNVISC-ONE INJECTION, THE REPORTER'S WIFE BEGAN EXPERIENCING MANY DIFFERENT SIDE EFFECTS INCLUDING RIGHT KNEE PAIN, RIGHT KNEE AND ANKLE SWELLING, KNEE HOT TO THE TOUCH, BACKACHE, LOW GRADE FEVER, AND PAIN IN BOTH HANDS. THE PT HAD BEEN TO SEVERAL DOCTORS AND NO DIAGNOSIS HAD BEEN CONFIRMED AT THE TIME OF THIS REPORT. TREATMENTS INCLUDED DICLOFENAC AND CORTISONE INJECTIONS ADMINISTERED IN THE BUTTOCK. THE ACTION TAKEN WITH SYNVISC-ONE WAS NOT PROVIDED. THE PT'S OUTCOME WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2011. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPEC CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPEC 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 55 YR Required Intervention