BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1833871 · Received September 8, 2010

    Report

    Report Number
    2246315-2010-00180
    Event Type
    Other
    Date Received
    September 8, 2010
    Report Date
    September 1, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT #: Q101. EVAL SUMMARY: ADD'L INFO IN THE FORM OF QA RESULTS WERE RECEIVED ON 9/7/10. THE PRODUCTION AND QC DOCUMENTATION FOR LOT# U0908, WITH EXP DATE (7/2012) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECS. NO ASSOCIATED NONCONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    KNEE WARMTH (JOINT WARMTH), KNEE REDNESS (ERYTHEMA), KNEE SWELLING (JOINT SWELLING), KNEE EFFUSION (JOINT EFFUSION). CASE DESCRIPTION: A SPONTANEOUS REPORT WAS RECEIVED ON 9/1/10 FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REP REGARDING A (B)(6) FEMALE PT, INITIALS (B)(6), WHO EXPERIENCED WARMTH, SWELLING, REDNESS, AND EFFUSION OF THE RIGHT KNEE AFTER TREATMENT WITH SYNVISC. THE PT HAD A HISTORY OF PREVIOUS TREATMENT WITH SYNVISC (2008). THE FIRST INJECTION IN CURRENT SERIES OF SYNVISC WAS ADMINISTERED ON AN UNK DATE. TWO LOT NUMBERS OF SYNVISC (Q101 AND U0908) WERE PROVIDED, BUT THE REPORTER WAS UNSURE WHICH LOT NUMBER THE PT RECEIVED IN THE RIGHT KNEE. PER QA, Q101 WAS AN INVALID SYNVISC LOT NUMBER. THE HCP WILL BE QUERIED TO VERIFY LOT NUMBERS. ON AN UNSPECIFIED DATE AFTER THE INJECTION, THE PT EXPERIENCED WARMTH, SWELLING, AND REDNESS IN THE RIGHT KNEE. TREATMENT INCLUDED ASPIRATION OF THE JOINT AND A CORTISONE INJECTION. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK U0908

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Required Intervention