BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BYD CARE DE2322 NIOSH N95 PARTICULATE RESPIRATOR

    MDR report key: 12511954 · Received September 22, 2021

    Report

    Report Number
    12511954
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    September 11, 2021
    Report Date
    September 21, 2021
    Manufacturer
    BYD PRECISION MANUFACTURE CO., LTD.
    Product Code
    MSH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RN REPORTED THAT AS SHE WAS PLACING A BYD N95 FACE MASK, THE STRAP ON ONE SIDE DISCONNECTED FROM THE MASK AND STRUCK HER LEFT EYE CAUSING A CORNEAL ABRASION INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413112 BYD CARE DE2322 NIOSH N95 PARTICULATE RESPIRATOR RESPIRATOR, SURGICAL MSH BYD PRECISION MANUFACTURE CO., LTD. TC-84A-9221 6200731

    Patients

    Seq Age Sex Outcome Treatment
    1 Other