BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYMASK

    MDR report key: 15422006 · Received September 14, 2022

    Report

    Report Number
    8022003-2022-00002
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Report Date
    September 14, 2022
    Manufacturer
    SOUTHMEDIC INC.
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER OF THE MASKS IS/ARE NOT KNOWN. END USER HAS STATED THAT THE TUBING HAS A RAISED RING OF MATERIAL AT THE END OF THE DETACHED TUBING. THIS DEMONSTRATES THAT THE SOLVENT PRESENCE WAS SUFFICIENT AND ABLE TO BOND THE TWO MATING COMPONENTS. THEREFORE; THE DEVICE IS ASSUMED TO BE MANUFACTURED AS INTENDED. COMPLAINT VERIFICATION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED AND THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    END USER REPORTED HAVING THREE MASKS WITH TUBING THAT LATER DETACHED AT NIGHT, WHILE SLEEPING (TUBING WAS CONNECTED PROPERLY IN THE BAG AND CAME OUT AFTER). EACH MASK WITH THE DETACHMENT ISSUE WAS USED FOR ROUGHLY ONE MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2496898 OXYMASK OXYGEN MASK BYG SOUTHMEDIC INC. OM-1425-8

    Patients

    Seq Age Sex Outcome Treatment
    1 Male