BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 19673836 · Received July 4, 2024

    Report

    Report Number
    3003442380-2024-11641
    Event Type
    Malfunction
    Date Received
    July 4, 2024
    Date of Event
    May 26, 2024
    Report Date
    July 4, 2024
    Manufacturer
    UNOMEDICAL A/S
    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 1902285 - MDR 3003442380-2024-11641 - DEVICE 1 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT FACED 3 EVENTS OF INFUSION SET FELL OFF DURING USE. THE EVENTS OCCURRED WITHIN 1 TO 12 HOURS OF INSERTION. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564917 INFUSION DEVICES - UNKNOWN INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown