BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVI SCOUT®

    MDR report key: 13541405 · Received February 16, 2022

    Report

    Report Number
    13541405
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    January 3, 2022
    Report Date
    January 20, 2022
    Manufacturer
    CIANNA MEDICAL, INC.
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN DEVICE WAS INITIALLY PLUGGED IN, IT DID NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8771 SAVI SCOUT® MARKER, RADIOGRAPHIC, IMPLANTABLE NEU CIANNA MEDICAL, INC. H2225693

    Patients

    Seq Age Sex Outcome Treatment
    1 Female