BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 19862228 · Received July 30, 2024

    Report

    Report Number
    3003442380-2024-17978
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 31, 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 (B)(4).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT TEN INFUSIONS SET FELL OFF WITHIN FEW HOURS OF USE. EVENT OCCURRED ON 01/05/2024, 12/05/2024, 19/05/2024, 22/05/2024, 27/05/2024, 30/05/2024, 10/06/2024, 13/06/2024, 20/06/2024, AND 23/06/2024. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200854 INFUSION DEVICES - UNKNOWN INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S INFUSION DEVICES - UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male