BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3O0625 - TRIO

    MDR report key: 13193198 · Received January 7, 2022

    Report

    Report Number
    1049092-2022-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Report Date
    December 10, 2021
    Manufacturer
    CONVATEC INC
    Product Code
    KOX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: SOLVENT, ADHESIVE TAPE. PRODUCT CODE: KOX. (B)(6). (B)(4). PMA/510K #: EXEMPT. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED BY RISK/SECURITY MANAGER THAT FIVE YEARS OLD PATIENT IN HOSPITAL, WHO WAS ADMITTED UNRELATED TO EVENT, HAD ELECTROENCEPHALOGRAM ELECTRODES IN THEIR HEAD FOR ROUTINE EXAMINATION. AFTER SUCCESSFUL ELECTROENCEPHALOGRAM READINGS THE ELECTRODES WERE BEING REMOVED FROM PATIENT SCALP WITH NILTAC SPRAY. NILTAC LIQUID CAUGHT ON FIRE WHICH CAUSED PATIENT'S HAIR CATCH ON FIRE. NURSE RAN TO SEARCH FOR FIRE BLANKET OR SIMILAR SUBSTITUTE OF BLANKET BUT PATIENT'S FATHER PRESENT IN THE ROOM WAS ABLE TO EXTINGUISH FIRE ON PATIENT'S HAIR. MORE STAFF WAS CALLED TO THE ROOM AND ROUTINE FIRST AID FOR BURNS WAS ADMINISTERED. RELATIVELY MINOR DAMAGES DESPITE CONSIDERABLE AMOUNT OF BURNED HAIR. EVENT RESULTED IN EXTRA NIGHT IN HOSPITAL FOR MONITORING THE PATIENT. THE HOSPITAL BEGAN INTERNAL INVESTIGATION ON THE NEXT DAY OF THE EVENT ON ROOT CAUSE. THEY REVIEWED THE SAFETY DATA SHEET FOR THE PRODUCT, INTERVIEWED THE PARENT AND ALL STAFF IN THE ROOM DURING THE EVENT, AND WERE CONSULTING DIFFERENT DEPARTMENTS. COMPLAINANT HAD NOT SUGGESTED NILTAC SPRAY TO BE AT FAULT BUT ALSO MENTIONED THE LOW FLASH POINT OF THIS SPRAY. COMPLAINANT CONSIDERED STATIC ELECTRICITY BEING A POSSIBLE CAUSE SINCE DAY OF THE EVENT WAS VERY COLD AND DRY. INTERNAL INVESTIGATION AT HOSPITAL IS STILL ONGOING, RESULTS WERE EXPECTED ON DECEMBER 17TH, 2021. ADDITIONAL INFORMATION WAS EXPECTED TO BE AVAILABLE ONLY UPON THE COMPLETION OF HOSPITAL'S INTERNAL CASE REPORT. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297516 L3O0625 - TRIO KOX CONVATEC INC 420787

    Patients

    Seq Age Sex Outcome Treatment
    1 5 Unknown