BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTACT DETACH

    MDR report key: 24624871 · Received March 18, 2026

    Report

    Report Number
    3003442380-2026-02337
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    February 23, 2026
    Report Date
    April 28, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244019317
    PMA / PMN Number
    K041545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6).

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN PORTUGAL. IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED ON (B)(6) 2026 DUE TO HIGH BLOOD GLUCOSE AND HIGH KETONE LEVELS. THE NURSE PROVIDED ASSISTANCE AND TREATMENT WAS GIVEN BY PEN INJECTION. THE HOSPITALIZATION LASTED LESS THAN 24 HOURS. THE KETONE VALUE WAS 3.8 MMOL/L. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299289 CONTACT DETACH UNO CONTACT DETACH G29 60/6 SC1 MIMX FPA UNOMEDICAL UM-D MMT-864A 6016495 05705244019317

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention