BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 24754513 · Received April 1, 2026

    Report

    Report Number
    3003442380-2026-06574
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    February 28, 2026
    Report Date
    March 3, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL (B)(4) DEVICE 2 OF 3. REQUEST WAS PERFORMED FOR ADDITIONAL INFORMATION INCLUDING LOT NUMBER; HOWEVER, LOT NUMBER WAS NOT PROVIDED. A COMPLAINT INVESTIGATION WAS INITIATED UNDER COMPLAINT INVESTIGATION. UNFORTUNATELY, NO SPECIFIC LOT NUMBER WAS IDENTIFIED, WHICH LIMITS THE ABILITY TO TRACE OR ANALYZE A PARTICULAR ITEM. INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN JAPAN. IT WAS REPORTED THAT PATIENT FACED THREE INFUSION SETS BENT CANNULA EVENTS ON (B)(6) 2026. THE INSERTION SITE WAS BUTTOCKS.THE BLOOD GLUCOSE LEVEL WAS 300 MG/DL AND THE PATIENT WAS TREATED BY PEN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812461 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A UNKNOWN 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention