BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N95 MASK N95 1805

    MDR report key: 5019041 · Received August 14, 2015

    Report

    Report Number
    MW5055619
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    July 29, 2015
    Report Date
    August 14, 2015
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RASH ON FACE AND SORE THROAT.

    Description of Event or Problem · 2

    SORE THROAT.

    Description of Event or Problem · 3

    SORE THROAT AND REACTIVE AIRWAY (HOSPITALIZED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537778 N95 MASK N95 1805 NONE FXX

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR
    2 43 YR
    3 52 YR Hospitalization| O