BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELSYN

    MDR report key: 14800611 · Received June 24, 2022

    Report

    Report Number
    3009595577-2022-00001
    Event Type
    Injury
    Date Received
    June 24, 2022
    Date of Event
    May 6, 2022
    Report Date
    July 1, 2022
    Manufacturer
    IBSA FARMACEUTICI ITALIA SRL
    Product Code
    MOZ
    UDI-DI
    08033638951057
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    AS REPORTED BY THE PATIENT, 4 DAYS AFTER RECEIVING A GELSYN INJECTION THE PATIENT WAS HOSPITALIZED FOR AN INFECTION AND TREATED WITH IV ANTIBIOTICS. THE PATIENT HAD TWO PREVIOUS GELSYN INJECTIONS WITH NO ADVERSE EVENTS REPORTED. AFTER RECEIVING THE THIRD INJECTION THE PATIENT REPORTED SWELLING AND PAIN IMMEDIATELY FOLLOWING THE INJECTION. THE PATIENT INDICATED THEY WERE UNABLE TO WALK OR RAISE THEIR LEFT LEG. PATIENT HAS SEVERE OSTEOATHRITIS IN THEIR LEFT KNEE. THE PATIENT WAS RELEASED FROM THE HOSPITAL IN STABLE CONDITION AND PRESCRIBED ANTIBIOTICS FOR 6 WEEKS.

    Description of Event or Problem · 0

    THERE HAS BEEN NO EVENT UPDATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609054 GELSYN HYALURONIC ACID MOZ IBSA FARMACEUTICI ITALIA SRL N/A 2109079 08033638951057

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention| H