BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVI SCOUT®

    MDR report key: 8860183 · Received August 5, 2019

    Report

    Report Number
    8860183
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    June 11, 2019
    Report Date
    July 15, 2019
    Manufacturer
    CIANNA MEDICAL, INC.
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SAVI SCOUT REFLECTOR THAT WAS PLACED IN THE BREAST WAS DEFECTIVE. PATIENT HAD TO RETURN THE DAY OF SURGERY TO HAVE A WIRE NEEDLE LOCALIZATION AS THE SAVI SCOUT DID NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653526 SAVI SCOUT® MARKER, RADIOGRAPHIC, IMPLANTABLE NEU CIANNA MEDICAL, INC. SSR75-01 ML04496

    Patients

    Seq Age Sex Outcome Treatment
    1 18615 DA Other