BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYMASK

    MDR report key: 7744671 · Received August 2, 2018

    Report

    Report Number
    8022032-2018-00005
    Event Type
    Injury
    Date Received
    August 2, 2018
    Date of Event
    May 19, 2018
    Report Date
    May 31, 2018
    Manufacturer
    SOUTHMEDIC INC.
    Product Code
    BYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    FACIAL BURNS ON PATIENT WHILE WEARING OXYMASK. IMPACT: INJURY TO PATIENT. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586467 OXYMASK OXYGEN MASK BYG SOUTHMEDIC INC. OM-1125-8

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization