BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED INFUSION SET

    MDR report key: 19902077 · Received August 3, 2024

    Report

    Report Number
    8021545-2024-02894
    Event Type
    Malfunction
    Date Received
    August 3, 2024
    Date of Event
    June 23, 2024
    Report Date
    August 3, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022683
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1930130- MDR 8021545-2024-02894- DEVICE 6 OF 8. E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 01-JUNE-2024, IT WAS REPORTED BY THE PATIENT THAT INFUSION SET FELL OFF WITHIN 7 DAYS OF USE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376325 MEDTRONIC EXTENDED INFUSION SET UNO EWIS BLUE 60/6 HCAP 10PK INT FPA UNOMEDICAL A/S MMT-431A UNKNOWN 05705244022683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown