BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 6847027 · Received September 6, 2017

    Report

    Report Number
    2438477-2017-00074
    Event Type
    Injury
    Date Received
    September 6, 2017
    Date of Event
    March 28, 2017
    Report Date
    July 24, 2017
    Manufacturer
    EMG TECHNOLOGY CO. LTD.
    Product Code
    JCX
    UDI-DI
    00822383151649
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    DRIVE DEVILBISS HEALTHCARE RECEIVED A NOTIFICATION FROM AN ATTORNEY OF AN INCIDENT INVOLVING A SUCTION MACHINE THAT DRIVE IMPORTS AND DISTRIBUTES. THE PATIENT WAS SLEEPING WITH THE SUCTION MACHINE NEXT TO HIS BED WHEN ALLEGEDLY HE GOT BURNT. HE WAS TAKEN TO THE HOSPITAL WHERE IT WAS DISCOVERED HE HAD SUFFERED A 2ND DEGREE BURN FROM TOUCHING THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624498 DRIVE MEDICAL SUCTION MACHINE JCX EMG TECHNOLOGY CO. LTD. 18600 00822383151649

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization