BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAVISCOUT

    MDR report key: 10338310 · Received July 21, 2020

    Report

    Report Number
    10338310
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    July 15, 2020
    Report Date
    July 20, 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, WITHOUT INCIDENT. AFTER LOCAL ANESTHESIA BEGAN TO WEAR OFF, PT NOTICED BURNING SENSATION AT SITE OF PROCEDURE. UPON INSPECTION, LARGE BURN NOTED AT THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770136 SAVISCOUT RADAR LOCALIZATION NEU CIANNA MEDICAL INC. SCOUT CHECK CHK-01

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other| S