BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHT SOURCE

    MDR report key: 16822681 · Received April 27, 2023

    Report

    Report Number
    16822681
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    November 8, 2019
    Report Date
    December 23, 2019
    Product Code
    FSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE LIGHT SOURCE BEING USED FOR THE CASE WAS NOT TURNED ON UNTIL NEEDED. AFTER THE START OF THE CASE, IT WAS NOTICED THAT THE PATIENT'S GOWN HAD A BURN MARK IN IT. IT WAS SEEN THAT A BURN MARK WAS ON THE DRAPES COVERING THE PATIENT. ONLY THE DRAPES HAD BEEN DAMAGED AND THE PATIENT WAS COVERED, THERE WAS NO KNOWN INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206504 LIGHT SOURCE LIGHT, SURGICAL, INSTRUMENT FSQ

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA Male