BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 19904774 · Received August 5, 2024

    Report

    Report Number
    3003442380-2024-19096
    Event Type
    Injury
    Date Received
    August 5, 2024
    Date of Event
    July 17, 2017
    Report Date
    July 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1932249- MDR 3003442380-2024-19096- DEVICE 2 OF 2. E1 PATIENT CITY: (B)(4). PATIENT COUNTRY:UNITED STATES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2017, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS FOR 2-7DAYS. PATIENT BLOOD GLUCOSE LEVEL WAS HIGH. PATIENT WAS TREATED WITH OVER THE COUNTER DRUGS, PRESCRIPTION DRUGS AND BASAL INSULIN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2293874 INFUSION DEVICES - UNKNOWN INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown Required Intervention| H