BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 20058189 · Received August 24, 2024

    Report

    Report Number
    3003442380-2024-22589
    Event Type
    Malfunction
    Date Received
    August 24, 2024
    Date of Event
    July 15, 2024
    Report Date
    July 26, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018426
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1950924 - MDR 3003442380-2024-22589 - DEVICE 2 OF 4.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SOUTH AFRICA. IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SET BLOCKED ALARM EVENT ON 15-JUL-2024 DUE TO SITE BLOCKINGS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293631 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002833 UNKNOWN 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose