BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIVISC

    MDR report key: 14986873 · Received July 11, 2022

    Report

    Report Number
    MW5110799
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Date of Event
    July 7, 2022
    Report Date
    July 8, 2022
    Manufacturer
    MEIJI PHARM SPAIN
    Product Code
    MOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TRIVISC SYRINGES ARE BREAKING DURING ADMINISTRATION WHERE HUB AND SYRINGE ATTACH. NEEDLE IS LEFT IN THE PATIENT AND THE SYRINGE WITH DRUG IS BROKEN OFF RESULTING IN INCOMPLETE ADMINISTRATION OF MEDICATION AND PATIENT REQUIRING TO BE STUCK AGAIN WITH A NEW SYRINGE; 5 SYRINGES OVER LAST 7 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292875 TRIVISC ACID, HYALURONIC, INTRAARTICULAR MOZ MEIJI PHARM SPAIN
    1292876 TRIVISC ACID, HYALURONIC, INTRAARTICULAR MOZ MEIJI PHARM SPAIN
    1292877 TRIVISC ACID, HYALURONIC, INTRAARTICULAR MOZ MEIJI PHARM SPAIN R1 50653000604
    1292878 TRIVISC ACID, HYALURONIC, INTRAARTICULAR MOZ MEIJI PHARM SPAIN
    1292879 TRIVISC ACID, HYALURONIC, INTRAARTICULAR MOZ MEIJI PHARM SPAIN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown