BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED

    MDR report key: 19901521 · Received August 3, 2024

    Report

    Report Number
    8021545-2024-02953
    Event Type
    Malfunction
    Date Received
    August 3, 2024
    Date of Event
    June 30, 2024
    Report Date
    July 5, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244023314
    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 (B)(4).- MDR DEVICE 2 OF 2. E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: (B)(6).

    Description of Event or Problem · 0

    REFERENCE NUMBER 1931135. EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET WAS LEAKING AT THE SITE. THE INFUSION SET WAS IN USE FOR THREE DAYS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995065 MEDTRONIC EXTENDED UNO EWIS BLUE 80/9 HCAP 3-PK INT FPA UNOMEDICAL A/S MMT-442AH 6005411 05705244023314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown