BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 24602571 · Received March 16, 2026

    Report

    Report Number
    3003442380-2026-02637
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    February 2, 2026
    Report Date
    February 24, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) DEVICE 1 OF 2. 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 THE UNITED STATES. IT WAS REPORTED THAT PATIENT EXPERIENCED TWO INFUSION SETS FELL OFF DURING USE DUE TO ADHESIVE ISSUE EVENT ON 02-FEB-2026 AND 05-FEB-2026. THE INFUSION SET WAS IN USE FOR FIVE TO SIX HOURS. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663192 UNKNOWN UNKNOWN FPA UNOMEDICAL DEVICES S.A. DE C.V. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female