BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED INFUSION SET

    MDR report key: 19857941 · Received July 29, 2024

    Report

    Report Number
    8021545-2024-02742
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 29, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    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 1925951 - MDR 8021545-2024-02742 - DEVICE 5 OF 7. E1: PATIENT CITY:(B)(6). PATIENT COUNTRY: NETHERLANDS.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN NETHERLANDS. THE PATIENT REPORTED THAT SEVEN INFUSION SETS DID NOT STICK AND ADHERE AFTER FEW DAYS. THE DURATION OF USE INCLUDES TWO INFUSION SETS AFTER 1 DAY, ONE INFUSION SET AFTER 2 HOURS, TWO INFUSION SETS AFTER 1.5 DAY, ONE INFUSION SET AFTER 5 HOURS AND ONE INFUSION AFTER 2 DAYS. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244951 MEDTRONIC EXTENDED INFUSION SET UNO EWIS BLUE 60/6 HCAP 10PK INT FPA UNOMEDICAL A/S MMT-431A 6004193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown