BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED INFUSION SET

    MDR report key: 19577923 · Received June 20, 2024

    Report

    Report Number
    8021545-2024-01270
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    May 21, 2024
    Report Date
    June 21, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244023079
    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 1892390- MDR 8021545-2024-01270- DEVICE 1 OF 2. (B)(6) .

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT TWO INFUSIONS SET TAPE NOT STICKING, JUST LIFTED AND PULLED LOSE DURING USE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577856 MEDTRONIC EXTENDED INFUSION SET UNO EWIS BLUE 80/9 HCAP 1-PK INT FPA UNOMEDICAL A/S MMT-442AJ UNKNOWN 05705244023079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown