BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED

    MDR report key: 19476266 · Received June 6, 2024

    Report

    Report Number
    8021545-2024-00858
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    May 5, 2024
    Report Date
    June 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244023161
    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 1880268- MDR 8021545-2024-00858 - DEVICE 1 OF 2. (B)(6).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES, ON (B)(6) 2024, THE PATIENT REPORTED THAT TWO INFUSION SET FELL OFF AS PRODUCT HAVE ISSUE ON TAPE NOT STICKING. THE ISSUE OF PRODUCT NOT ADHERING IS INFUSION SET IS INSERTED ON ABDOMEN AND AFTER 3 DAYS THE INFUSION SET IS PEELING OFF. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244395 MEDTRONIC EXTENDED UNO EWIS BLUE 60/6 HCAP 3-PK INT FPA UNOMEDICAL A/S MMT-431AH 6005666 05705244023161

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown