BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONTERIS MEDICAL

    MDR report key: 5913323 · Received August 30, 2016

    Report

    Report Number
    MW5064408
    Event Type
    Injury
    Date Received
    August 30, 2016
    Date of Event
    July 25, 2016
    Report Date
    July 26, 2016
    Manufacturer
    MONTERIS MEDICAL
    Product Code
    HQB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    DURING NEUROBLATE PROCEDURE, TIP OF PROBE WAS DETACHED FROM BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564916 MONTERIS MEDICAL SIDEFIRE DIRECTIONAL LASER PROBE HQB MONTERIS MEDICAL NBP-001-01

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization