BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 1821708 · Received August 27, 2010

    Report

    Report Number
    2246315-2010-00167
    Event Type
    Other
    Date Received
    August 27, 2010
    Date of Event
    July 14, 2010
    Report Date
    August 10, 2010
    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

    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

    PINS AND NEEDLES SENSATION OF THE RIGHT KNEE [PARAESTHESIA]. INCREASE IN RIGHT KNEE PAIN RADIATING DOWN TO ANKLE /RIGHT KNEE WAS PAINFUL TO THE TOUCH [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A (B)(6) FEMALE PT, INITIAL (B)(6). THE PT HAD A HISTORY OF OSTEOARTHRITIS AND PREVIOUS SYNVISC INJECTIONS IN (B)(6) 2008 AND (B)(6) 2009. THE PT RECEIVED A SYNVISC-ONE INJECTION IN THE RIGHT KNEE ON (B)(6) 2010. TWO DAYS AFTER THE SYNVISC-ONE INJECTION, THE PT HAD AN INCREASE IN RIGHT KNEE PAIN RADIATING DOWN TO THE ANKLE. THE RIGHT KNEE WAS PAINFUL TO THE TOUCH. THE PT ALSO DESCRIBED A PINS AND NEEDLES SENSATION OF THE RIGHT KNEE WHICH WOULD COME AND GO. THE PT WAS TREATED WITH ICE AND METHYLPREDNISOLONE 4MG TAPERED DOSE OVER 6 DAYS. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT'S OUTCOME WAS UNK. MFR'S COMMENT: THE BENEFIT RISK RELATIONSHIP OF SYNVISC ONE IS NOT AFFECTED BY THIS REPORT.

    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 70 YR Required Intervention