BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 258699 · Received January 12, 2000

    Report

    Report Number
    1825511-2000-00001
    Event Type
    Injury
    Date Received
    January 12, 2000
    Date of Event
    January 22, 1998
    Report Date
    January 12, 2000
    Manufacturer
    PURITAN BENNETT CRYOGENIC EQUIPMENT DIVISION
    Product Code
    GXH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE ATTORNEY FOR THE PLAINTIFF REPORTED THE FOLLOWING INFO: (1) WHILE AT THE HOSPITAL, PLAINTIFF WAS PERMITTED TO DEVELOP A LARGE BURN/ULCERATION ON HIS THIGH/GROIN AREA. (2) IT IS BELIEVED THAT THE BURN/SORE RESULTED FROM CONTACT WITH THE OXYGEN MACHINE. (3) THE HOSPITAL WAS NEGLIGENT IN THE PLACEMENT AND MONITORING OF THE OXYGEN MACHINE. (4) THE PT HAS SINCE PASSED AWAY UNRELATED TO THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK GXH PURITAN BENNETT CRYOGENIC EQUIPMENT DIVISION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention