BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE INJ 8MG/ML

    MDR report key: 6173799 · Received December 9, 2016

    Report

    Report Number
    MW5066699
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    December 9, 2016
    Report Date
    December 9, 2016
    Manufacturer
    UNK
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT IS EXPERIENCING SIGNIFICANT PAIN AND SWELLING IN THE KNEE INJECTION WAS ADMINISTERED TO. IT IS 2 DAYS FOLLOWING INJECTION. PT REPORTS TO TWO PREVIOUS INJECTIONS IN 2013 AND 2014 WITHOUT ANY SIMILAR REACTIONS. DIAGNOSIS OR REASON FOR USE: (B)(4). IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815021 SYNVISC ONE INJ 8MG/ML SYNVISC ONE INJ 8MG/ML MOZ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR