BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AX-KN95

    MDR report key: 14162262 · Received April 19, 2022

    Report

    Report Number
    MW5109197
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Report Date
    April 18, 2022
    Manufacturer
    DONGGUAN AOXING AUDIO VISUAL EQUIPMENT CO.,LTD.
    Product Code
    MSH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PURCHASED "KN95" MASKS FROM (B)(6). THE MASKS ARE PRODUCED BY A COMPANY CALLED (B)(6). THE MASKS LACK ANY OFFICIAL MARKINGS OR DOCUMENTATION ABOUT THEIR COMPOSITION. FDA SAFETY REPORT IDS# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2626940 AX-KN95 RESPIRATOR, SURGICAL MSH DONGGUAN AOXING AUDIO VISUAL EQUIPMENT CO.,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male