BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYTOTE DTE

    MDR report key: 13694056 · Received March 8, 2022

    Report

    Report Number
    1526809-2022-00001
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    January 4, 2022
    Report Date
    January 4, 2022
    Manufacturer
    WESTERN/SCOTT FETZER CO.
    Product Code
    CAN
    PMA / PMN Number
    NONE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL 30-DAY REPORT FILING WAS DELAYED DUE TO THE ENROLLMENT PROCESS.

    Description of Event or Problem · 0

    AS HOSPITAL PERSONNEL ADMINISTERED OXYGEN TO THE PATIENT, THE PATIENT COMPLAINED OF AN ACRID SMELL WHICH PROMPTED THE PATIENT TO START COUGHING. THE UNIT WAS SHUT OFF AND REMOVED FROM THE ROOM. THE PATIENT'S COUGHING IMMEDIATELY SUBSIDED. NO INJURY OCCURRED, AND TREATMENT ASSOCIATED WITH THIS EVENT WAS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968901 OXYTOTE DTE DIGITAL OXYGEN REGULATOR CAN WESTERN/SCOTT FETZER CO. MNDR-600 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown