BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELSYN-3 ZILRETTA

    MDR report key: 8339466 · Received February 13, 2019

    Report

    Report Number
    MW5084046
    Event Type
    Injury
    Date Received
    February 13, 2019
    Date of Event
    December 5, 2018
    Report Date
    February 8, 2019
    Manufacturer
    IBSA FARMACEUTICI ITALIA SRL
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INJECTION OF GELSYN-3 INTO BOTH KNEES DONE 3 TIMES: DATE (B)(6) 2018, (B)(6) 2018, (B)(6) 2018. RESULT: BLOOD PRESSURE HIGH, DIZZINESS, CHILLS OFF AND ON, LACK OF APPETITE, ITCHING, SWELLING. INJECTION AT MEDICAL CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131218 GELSYN-3 ZILRETTA ACID, HYALURONIC, INTRAARTICULAR MOZ IBSA FARMACEUTICI ITALIA SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| S