BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELSYN - 3

    MDR report key: 8425001 · Received March 14, 2019

    Report

    Report Number
    MW5084943
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    March 11, 2019
    Report Date
    March 11, 2019
    Manufacturer
    IBSA FARMACEUTICI ITALIA SRL
    Product Code
    MOZ
    UDI-DI
    89130311101
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT'S PHYSICIAN REPORTS THAT PT EXPERIENCED ITCHING, A RASH, AND SEVERELY INCREASED PAIN AROUND THE INJECTION SITE AND HER KNEES AFTER BEING INJECTED WITH GELSYN. HER PHYSICIAN SWITCHED HER OVER TO HYALGAN AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212533 GELSYN - 3 ACID, HYALURONIC, INTRAARTICULAR MOZ IBSA FARMACEUTICI ITALIA SRL 89130311101

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR