BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED INFUSION SET

    MDR report key: 19786263 · Received July 20, 2024

    Report

    Report Number
    8021545-2024-02280
    Event Type
    Malfunction
    Date Received
    July 20, 2024
    Date of Event
    May 22, 2024
    Report Date
    July 20, 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

    E1: (B)(6). PATIENT COUNTRY: FRANCE.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN FRANCE. IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT EXPERIENCED ISSUE WITH INFUSION SET WAS FELL OFF DURING USE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033686 MEDTRONIC EXTENDED INFUSION SET UNO EWIS BLUE 60/6 HCAP 10PK INT FPA UNOMEDICAL A/S MMT-431A 6004018 05705244022683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown