BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELSYN KNEE INJECTION

    MDR report key: 9596341 · Received January 15, 2020

    Report

    Report Number
    MW5092307
    Event Type
    Injury
    Date Received
    January 15, 2020
    Date of Event
    December 14, 2019
    Report Date
    January 15, 2020
    Manufacturer
    IBSA FARMACEUTICI ITALIA SRL
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATED SHE RECEIVED THE INJECTION IN BOTH KNEES 16.8 MG, 2ML, ON (B)(6) 2019. CALLER EXPERIENCED WORSENED PAIN IN BOTH KNEES AND ITCHING IN HER LEFT LEG. THE PAIN HAS CAUSED DIFFICULTY AMBULATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57077 GELSYN KNEE INJECTION ACID, HYALURONIC, INTRAARTICULAR MOZ IBSA FARMACEUTICI ITALIA SRL
    57078 GELSYN KNEE INJECTION ACID, HYALURONIC, INTRAARTICULAR MOZ IBSA FARMACEUTICI ITALIA SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other