BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYD. NIOSH N95 REPIRATOR

    MDR report key: 12727949 · Received October 29, 2021

    Report

    Report Number
    MW5105033
    Event Type
    Injury
    Date Received
    October 29, 2021
    Date of Event
    October 27, 2021
    Report Date
    October 27, 2021
    Manufacturer
    BYD PRECISION MANUFACTURE CO.,LTD.
    Product Code
    MSH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SEVERE BURNING IN THROAT; NIOSH RESPIRATOR. TC-84A-9221. WORE N95 RESPIRATOR THE DAY BEFORE AND WOKE UP WITH TERRIBLE BURNING IN MY THROAT, WHICH SLOWLY WENT AWAY AFTER NOT WEARING IT. CHEMICALS IN MASK SHOULD BE EVALUATED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616842 BYD. NIOSH N95 REPIRATOR RESPIRATOR, SURGICAL MSH BYD PRECISION MANUFACTURE CO.,LTD. TC-84A-9221 6200701

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other