BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 19839178 · Received July 26, 2024

    Report

    Report Number
    3003442380-2024-16792
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    June 20, 2024
    Report Date
    July 26, 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

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1922530 - MDR 3003442380-2024-16792 - DEVICE 2 OF 2.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 06-20-2024 PATIENT'S PARENT REPORTED THAT 2 INFUSION SETS FELL OFF DURING USE. THE INFUSION SET WAS IN USE FOR NOT MORE THAN 24 HOURS. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587198 INFUSION DEVICES - UNKNOWN UNKNOWN FPA UNOMEDICAL A/S UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male