BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE PARADIGM

    MDR report key: 19641754 · Received July 1, 2024

    Report

    Report Number
    3003442380-2024-11265
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    May 23, 2024
    Report Date
    September 11, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244019645
    PMA / PMN Number
    K162812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT HE RECEIVES AN INSULIN FLOW BLOCK ALARM AND INFECTION ON THE INSERTION SITE, PAIN, AND GIT INFECTED. FOR THE TREATMENT HE RECEIVES AN OINTMENT. INFUSION SET WAS PLACED IN HIP AREA. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786441 SILHOUETTE PARADIGM UNO COMFORT SHORT 80/13 SC1 MINI FPA UNOMEDICAL A/S MMT-383A 6004350 05705244019645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male