BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYD N95 NIOSH PARTICULATE RESPIRATOR

    MDR report key: 13472530 · Received February 4, 2022

    Report

    Report Number
    MW5107234
    Event Type
    Injury
    Date Received
    February 4, 2022
    Date of Event
    February 1, 2022
    Report Date
    February 2, 2022
    Manufacturer
    BYD PRECISION MANUFACTURE CO., LTD.
    Product Code
    MSH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SERVE ALLERGIC REACTION TO THE BYD-N95 NIOSH PARTICULATE RESPIRATOR, USA CDC + FDA REGISTERED AND APPROVED FOR MEDICAL USE WITHIN THE USA. SOLD TO HOSPITALS. NIOSH TC-84A-9221 PURCHASED FROM (B)(4) AT (B)(4). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452414 BYD N95 NIOSH PARTICULATE RESPIRATOR RESPIRATOR, SURGICAL MSH BYD PRECISION MANUFACTURE CO., LTD. DE2322

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Disability ASPIRIN