BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOVISC (HYALURONATE SODIUM, STABILIZED)

    MDR report key: 11752233 · Received April 29, 2021

    Report

    Report Number
    MW5101085
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 21, 2021
    Report Date
    April 28, 2021
    Manufacturer
    DEPUY MITEK / ANIKA THERAPEUTICS, INC.
    Product Code
    MOZ
    UDI-DI
    59676082001
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    MONOVISC (HYALURONATE SODIUM, STABILIZED) INJECTION FOR A PATIENT WAS FOUND TO HAVE WHITE MATERIAL FLOATING IN THE SYRINGE. NDC 59676-0820-01 LOT # 0000004864 MANUFACT: DEPUY MITEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646164 MONOVISC (HYALURONATE SODIUM, STABILIZED) ACID, HYALURONIC, INTRAVASCULAR MOZ DEPUY MITEK / ANIKA THERAPEUTICS, INC. 0000004864 59676082001

    Patients

    Seq Age Sex Outcome Treatment
    1