BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 19663547 · Received July 3, 2024

    Report

    Report Number
    3003442380-2024-11602
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    May 14, 2024
    Report Date
    July 3, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016712
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1901878- MDR 3003442380-2024-11602- DEVICE 1 OF 5.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED ISSUE WITH 5 INFUSION SET'S ADHESIVE ON (B)(6) 2024.THE INFUSION SET FELL OFF DURING USE. THE INFUSION SET WAS IN USE FOR 1-2 DAYS. THE PATIENT CONFIRMED THE SET FELL OFF WHILE DOING PHYSICAL ACTIVITY/SWEATING, SWIMMING, OR BATHING. THE PATIENT RESOLVED THE EVENT BY REPLACING INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579492 INSET INSET I 2-PACK 60/6 GREY TCAP FPA UNOMEDICAL A/S 1010900 6004403 05705244016712

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female