BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYMASK

    MDR report key: 10053828 · Received May 13, 2020

    Report

    Report Number
    8022032-2020-00001
    Event Type
    Injury
    Date Received
    May 13, 2020
    Date of Event
    April 6, 2020
    Report Date
    May 12, 2020
    Manufacturer
    SOUTHMEDIC INC.
    Product Code
    BYG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS CONTACTED THREE TIMES FOR FURTHER DETAILS TO AID IN THE INVESTIGATION (I.E. PART NUMBER, LOT NUMBER, SAMPLES/PICTURES, ETC.). NO RESPONSE HAS BEEN RECEIVED. SHOULD FURTHER INFORMATION BE MADE AVAILABLE, THIS INFORMATION SHALL BE REPORTED IF APPLICABLE.

    Description of Event or Problem · 1

    A PATIENT USES THE OXYMASK AT NIGHT WHEN SLEEPING. THEY WOKE UP OUT OF BREATH AND NOTICED THAT THE HOSE HAD CAME OUT OF THE MASK. THEY WERE ABLE TO LOCATE THE OXYGEN LINE AND PULL THE END OUT FROM UNDER THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518073 OXYMASK OXYMASK BYG SOUTHMEDIC INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening