BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAVISCOUT

    MDR report key: 10379308 · Received July 31, 2020

    Report

    Report Number
    10379308
    Event Type
    Injury
    Date Received
    July 31, 2020
    Date of Event
    June 29, 2020
    Report Date
    July 29, 2020
    Manufacturer
    CIANNA MEDICAL INC.
    Product Code
    NEU
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT NEEDLE LOCALIZATION SAVI SCOUT PROCEDURE ON (B)(6) 2020. FACILITY MADE AWARE OF BURN OCCURRING ON THE PT'S LEFT BREAST, DESCRIBED AS A 3RD DEGREE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812685 SAVISCOUT RADAR LOCALIZER NEU CIANNA MEDICAL INC. SCOUT CHECK REF CHK-01

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| S