BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N95 MASK

    MDR report key: 11595088 · Received March 30, 2021

    Report

    Report Number
    MW5100367
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    February 26, 2021
    Report Date
    March 26, 2021
    Manufacturer
    UNK
    Product Code
    NZJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SEVERE SHORTNESS OF BREATH; WALKING UP A SLIGHT GRADE I NOTICED I COULD NOT BREATHE AND BECAME DISORIENTED AND NEARLY COLLAPSED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489967 N95 MASK RESPIRATOR, N95, FOR USE BY THE GENERAL PUBLIC IN PUBLIC HEALTH MEDICAL EMERGENC NZJ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other