BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELSYN - 3 INJ 16.8 / 2ML

    MDR report key: 8636570 · Received May 22, 2019

    Report

    Report Number
    MW5086858
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    May 22, 2019
    Report Date
    May 16, 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

    (B)(6) W/ DR (B)(6) OFFICE, MD IS AWARE THAT PER THE MFR, "THE EFFECTIVENESS OF A SINGLE TREATMENT CYCLE OF MORE THAN 3 INJECTIONS HAS NOT BEEN ESTABLISHED," HOWEVER PER (B)(6), THE PRESCRIBER WOULD LIKE TO CONTINUE WITH THE GELSYN-3 INJECTED WEEKLY FOR 5 WKS, PLEASE CONTINUE WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423871 GELSYN - 3 INJ 16.8 / 2ML ACID, HYALURONIC, INTRAARTICULAR MOZ IBSA FARMACEUTICI ITALIA SRL 89130311101

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR