BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC 16MG/2ML

    MDR report key: 5038654 · Received August 25, 2015

    Report

    Report Number
    MW5055818
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 24, 2015
    Manufacturer
    SANOFI-AVENTIS
    Product Code
    MOZ
    UDI-DI
    58468009001
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT HAD SYNVISC INJECTION ON (B)(6) 2015 AND PT'S SON REPORTS THAT HER KNEE HAS BEEN INFLAMED AND HOT SINCE SHE TOOK THE INJECTION. HE STATES THERE IS SWELLING AT THE KNEE CAP. PT ALSO IS GETTING CHILLS AND CAN'T FLEX/MOVE THE JOINT. DOSE OR AMOUNT: UNK - MD ADMIN, FREQUENCY: BILATERAL. DIAGNOSIS OR REASON FOR USE: OSTEOARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560180 SYNVISC 16MG/2ML INTRA-ARTICULAR HYALURONIC ACID MOZ SANOFI-AVENTIS 5RSA003A 58468009001

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other