BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 19737511 · Received July 14, 2024

    Report

    Report Number
    3003442380-2024-14527
    Event Type
    Injury
    Date Received
    July 14, 2024
    Date of Event
    June 11, 2024
    Report Date
    January 17, 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), PATIENT COUNTRY: CANADA.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT WIFE THAT HER HUSBAND WAS HOSPITALIZED DUE TO HYPOGLYCEMIA AND COMA FOR 40 MINUTES. LOW BLOOD GLUCOSE LEVEL WAS 0.8 MMOL/L. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392158 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