BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 19862226 · Received July 30, 2024

    Report

    Report Number
    3003442380-2024-17734
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    April 15, 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) - DEVICE 1 OF 8.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. ON 15-APRIL-2024, IT WAS REPORTED BY THE PATIENT THAT EIGHT INFUSIONS SET FELL OFF WITHIN FEW HOURS OF USE. EVENT OCCURRED ON 15/04/2024, 29/04/2024, 07/05/2024, 13/05/2024, 25/05/2024, 30/05/2024, 11/06/2024, AND 22/06/2024. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200852 INFUSION DEVICES - UNKNOWN INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S INFUSION DEVICES - UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male