BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE-T PARADIGM

    MDR report key: 19673320 · Received July 4, 2024

    Report

    Report Number
    3003442380-2024-11382
    Event Type
    Malfunction
    Date Received
    July 4, 2024
    Date of Event
    June 3, 2024
    Report Date
    July 4, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244019379
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1901717- MDR 3003442380-2024-11382- DEVICE 1 OF 3. (B)(4).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT THREE INFUSIONS FELL OFF, TAPE NOT STICKING WITHIN ONE DAY OF USE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973640 SURE-T PARADIGM UNO CONTACT DETACH G29 60/8 SC1 MIMX FPA UNOMEDICAL A/S MMT-874A 6004459 05705244019379

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown