BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 6188878 · Received December 9, 2016

    Report

    Report Number
    MW5066811
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 29, 2016
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    PT DIDN'T ORDER MEDICATION. MD GAVE HER THE MEDICATION SYNVISC AND PT GOT AN ALLERGIC REACTION. MD STOPPED THE MEDICATION, PT WILL NOT BE TAKING THE MEDICATION SYNVISC. NOTHING ELSE KNOWN. DOSE OR AMOUNT: 16MG, FREQUENCY: QWK, ROUTE: IA. DIAGNOSIS OR REASON FOR USE: OA; 8MG/ML (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815124 SYNVISC ACID, HYALURONIC, INTRA ARTICULAR MOZ

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other