BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINAL ASSEMBLY, H-300

    MDR report key: 1592412 · Received January 27, 2010

    Report

    Report Number
    1825511-2010-00002
    Event Type
    Injury
    Date Received
    January 27, 2010
    Date of Event
    January 11, 2010
    Report Date
    January 11, 2010
    Manufacturer
    PLAINFIELD-LOX-RX
    Product Code
    BYJ
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. IF AND WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED: THE PATIENT STARTED USING LIQUID OXYGEN IN (B) (6) OF 2009. SOMETIME IN THE (B) (6) OF 2009, THE PATIENT BEGAN EXPERIENCING RINGING IN HIS EARS. THE PATIENT SOUGHT MEDICAL ATTENTION FOR THE ISSUE AND WAS ADVISED THAT HE HAD SOME DEGREE OF HEARING LOSS. THE PATIENT ATTRIBUTES THE CONDITION TO THE NOISE CAUSED WHEN FILLING HIS PORTABLE LIQUID OXYGEN DEVICE. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINAL ASSEMBLY, H-300 PORTABLE LIQUID OXYGEN UNIT BYJ PLAINFIELD-LOX-RX H300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability