BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILHOUETTE PARADIGM

    MDR report key: 15741724 · Received November 7, 2022

    Report

    Report Number
    8021545-2022-00183
    Event Type
    Malfunction
    Date Received
    November 7, 2022
    Report Date
    November 7, 2022
    Product Code
    FPA
    UDI-DI
    05705244019584
    PMA / PMN Number
    K162812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN SOUTH KOREA. ON (B)(6) 2022, IT WAS REPORTED THAT THE INFUSION SET'S TUBING GOT DETACHED AT THE CONNECTOR. THE SITE LOCATION PATIENT'S ABDOMEN AND THE PUMP WAS IN THE RIGHT POCKET. THE INFUSION HAD BEEN USED FOR ONE DAY. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182303 SILHOUETTE PARADIGM UNO COMFORT SHORT 60/13 SC1 MIN FPA MMT-381A UNKNOWN 05705244019584

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown