BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSCOE

    MDR report key: 9152520 · Received October 3, 2019

    Report

    Report Number
    3012316249-2019-00028
    Event Type
    Injury
    Date Received
    October 3, 2019
    Report Date
    October 3, 2019
    Manufacturer
    DANYANG XINYA VALVE CO., LTD
    Product Code
    CAN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPANY HAD A SITUATION AT A NURSING HOME WHERE THERE WAS A FIRE INVOLVING A REGULATOR. IT WAS ABOUT A 2 FOOT FLAME THAT WENT OUT IN A SECOND. THEY NOTICED THE GAUGE WAS BENT, BUT NOT SURE IF THAT HAPPENED BEFORE OR AS A RESULT OF THE FIRE. THE WASHER WAS DAMAGED IN THE FIRE. A CNA WAS HANDLING THE TANK, SHE RECEIVED FIRST DEGREE BURNS TO HER HANDS. SHE WENT TO EMERGENCY ROOM AND THEY GAVE HER SOME CREAM AND SENT HER HOME SAME DAY. FROM WHAT THEY WERE TOLD BY EYEWITNESS IT SEEMS THE FLAME CAME OUT ON TOP FROM WHERE THE REGULATOR MEETS THE OUTLET ON THE CYLINDER. THE REGULATOR HAD BEEN USED BEFORE. NOT KNOWN WHEN WASHER WAS LAST REPLACED, ITS NOT SOMETHING THAT TYPICALLY GETS DOCUMENTED. THEY ARE SUPPOSED TO INSPECT BEFORE EVERY USE AND REPLACE AS NECESSARY. THE BOTTOM OF REGULATOR RECEIVED THE MOST DAMAGE. THERE WAS A CHUNK OF METAL MISSING THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947500 ROSCOE REGULATOR 0-15 LPM CAN DANYANG XINYA VALVE CO., LTD RMI-15MINI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization