BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2945067 · Received January 31, 2013

    Report

    Report Number
    2246315-2013-00021
    Event Type
    Other
    Date Received
    January 31, 2013
    Report Date
    January 24, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2013. 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. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    PSEUDOSEPTIC REACTION [INFLAMMATION]. SWELLING IN KNEE [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORTED WAS RECEIVED ON (B)(4) 2013 FROM A PHYSICIAN VIA SALES REP REGARDING A PT, (DEMOGRAPHICS NOT PROVIDED), INITIALS UNK. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT INITIATED TREATMENT WITH SYNVISC ONE (HYLAN G-F 20) INJECTION, ROUTE AND DOSAGE REGIMEN NOT PROVIDED. THE LOT NUMBER OF SYNVISC ONE WAS NOT PROVIDED. IT WAS REPORTED THAT ON AN UNSPECIFIED DATE, THE PT HAD A PSEUDOSEPTIC REACTION TO SYNVISC-ONE INJECTION. THE PT VISITED THE EMERGENCY ROOM WITH SWELLING IN THE KNEE. THE PT WAS GIVEN STEROID INJECTION IN THE KNEE AT EMERGENCY ROOM AND WAS SENT HOME ON ORAL NON STEROIDAL ANI INFLAMMATORY DRUGS. ON AN UNSPECIFIED DATE, THE PT RECOVERED FROM THE EVENTS OF PSEUDOSEPTIC REACTION AND SWELLING IN KNEE. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR BOTH THE EVENTS WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SYNVISC ONE AND BOTH THE EVENTS WAS NOT PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42094 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention