BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 20046464 · Received August 23, 2024

    Report

    Report Number
    3003442380-2024-20405
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 18, 2024
    Report Date
    May 28, 2026
    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

    PATIENT CITY: (B)(6).

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN KUWAIT. IT WAS REPORTED THAT THE PATIENT FACED HIGH BLOOD GLUCOSE LEVEL OF 21 MMOL/L. THEREFORE, THE PATIENT WAS HOSPITALISED FOR THREE DAYS. DURING HOSPITALISATION, THE PATIENT RECEIVED INTRAVENOUS INSULIN DRIP. CURRENTLY, THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 12 MMOL/L. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071188 INFUSION DEVICES - UNKNOWN INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S INFUSION DEVICES - UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H