BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED

    MDR report key: 19685421 · Received July 6, 2024

    Report

    Report Number
    8021545-2024-01785
    Event Type
    Malfunction
    Date Received
    July 6, 2024
    Date of Event
    May 8, 2024
    Report Date
    July 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022805
    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 1904311 - MDR 8021545-2024-01785 - DEVICE 1 OF 4. (B)(6).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 4 INFUSION SET TAP NOT STICKING DURING SHOWER EVENT ON (B)(6) 2024. CAUSE PRODUCT NOT ADHERING DUE GOT WET. NON-SERIALIZED PRODUCT BEING REPLACED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473378 MEDTRONIC EXTENDED UNO EWIS BLUE 60/9 HCAP 10PK INT FPA UNOMEDICAL A/S MMT-441A 6004219 05705244022805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown