BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 19814685 · Received July 24, 2024

    Report

    Report Number
    3003442380-2024-16068
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    June 5, 2024
    Report Date
    July 24, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON 05-JUNE-2024, IT WAS REPORTED BY THE PATIENT THAT INFUSIONS SET FELL OFF WITHIN 6 HOURS OF USE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349372 INFUSION DEVICES - UNKNOWN INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S INFUSION DEVICES - UNKNOWN 6001940

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female