BEUDAMED
    FDA Adverse Event Other Summary report: N

    LASER PERIPHERALS

    MDR report key: 2713876 · Received August 7, 2012

    Report

    Report Number
    1221543-2012-00001
    Event Type
    Other
    Date Received
    August 7, 2012
    Date of Event
    May 24, 2012
    Report Date
    July 31, 2012
    Manufacturer
    LASER PERIPHERALS LLC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF CIRCUMSTANCES IS DIFFICULT WITHOUT HAVING DEVICE TO ANALYZE. USER FACILITY REPORTED INCIDENT THROUGH MDR (B)(4).

    Description of Event or Problem · 1

    MEDICAL CENTER CONTACTED LASER PERIPHERALS TO REPORT INCIDENT ON (B)(6) 2012. INDICATED A FIRE OCCURRED IN PT AIRWAY. REPORTER INFERRED THAT THEY WERE STILL COLLECTING INFO ON THE EVENT. THEY HAD STATED THAT THERE WAS NO POSITIVE INDICATION THAT THE DEVICE HAD MALFUNCTIONED. DEVICE WAS NOT AVAILABLE FOR ANALYSIS AT TIME OF REPORT, BUT MAY BE MADE AVAILABLE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER PERIPHERALS DSLF-60 GEX LASER PERIPHERALS LLC. DSLF-60 K-11139

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R