BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 24786804 · Received April 5, 2026

    Report

    Report Number
    3003442380-2026-88598
    Event Type
    Injury
    Date Received
    April 5, 2026
    Date of Event
    March 4, 2026
    Report Date
    April 21, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: PORTUGAL.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURED IN PORTUGAL. IT WAS REPORTED THAT THE PATIENT FACED HIGH BLOOD GLUCOSE LEVEL, DIABETIC KETOACIDOSIS EVENT AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2026. THE BLOOD GLUCOSE LEVEL WAS 450 MG/DL AND THE PATIENT WAS TREATED WITH INTRAVENOUS INSULIN DRIP. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848101 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A 6014722 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization