BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER PERIPHERALS LLC DBLF-100

    MDR report key: 3811800 · Received May 9, 2014

    Report

    Report Number
    MW5036071
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    February 6, 2014
    Report Date
    May 8, 2014
    Manufacturer
    LASER PERIPHERALS LLC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NURSE AT END USER FACILITY REPORTED THAT PRODUCT WAS USED IN A PROCEDURE WHERE AN AIRWAY IGNITION WAS WITNESSED. NO EVIDENCE OF DEVICE FAILURE OR CAUSE OF ADVENT. NOT MUCH INFO COULD BE RECEIVED FROM USER FACILITY. DIAGNOSIS OR REASON FOR USE: BRONCHIAL YAG LASER ABLATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281295 LASER PERIPHERALS LLC DBLF-100 LASER FIBER GEX LASER PERIPHERALS LLC DBLF-100 LP-713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention