BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELSYN -3 16.8MG/2ML SYR

    MDR report key: 11602341 · Received March 31, 2021

    Report

    Report Number
    MW5100475
    Event Type
    Injury
    Date Received
    March 31, 2021
    Date of Event
    March 15, 2021
    Report Date
    March 29, 2021
    Manufacturer
    IBSA FARMACEUTICI ITALIA SRL
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    MEMBER IS HAVING PAIN IN HIS RIGHT KNEE. MEMBER HAS NOT FILLED WITH ARA SINCE (B)(6) 2020. PT'S FILE INDICATES PATIENT FILLED WITH ANOTHER PHARMACY RECENTLY. MD: (B)(6). DRUG LOT AND EXPIRATION NOT PROVIDED. CURRENT RX IS INJECT 1 SYRINGE INTRAARTICULARLY INTO THE RIGHT KNEE ONCE A WEEK FOR 3 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497527 GELSYN -3 16.8MG/2ML SYR ACID, HYALURONIC, INTRAARTICULAR MOZ IBSA FARMACEUTICI ITALIA SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR