BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUSTEEL

    MDR report key: 19571181 · Received June 19, 2024

    Report

    Report Number
    3003442380-2024-09198
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    April 23, 2024
    Report Date
    May 29, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018457
    PMA / PMN Number
    K041545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1891639 - MDR 3003442380-2024-09198 - DEVICE 2 OF 2.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT WENT TO EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED ON (B)(6) 2024. HIGHEST GLUCOSE LEVELS OBSERVED WERE AROUND 600 MG/DL DURING THE EVENT. PATIENT WAS HAVING HIGH KETONES WHICH WAS INDICATED LIFE THREATENING BY THE DOCTOR. HE TOOK CORRECTION BOLUS VIA PUMP TO ADDRESS HIGH BLOOD GLUCOSE AND GOT INTRAVENOUS FLIDS OF SALINE AND INSULIN AS HOSPITALIZATION TREATMENT. PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2024. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604660 TRUSTEEL UNO CONTACT DETACH G29 80/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002834 UNKNOWN 05705244018457

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| L