BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHB MEDICAL FACE MASK

    MDR report key: 10442059 · Received August 21, 2020

    Report

    Report Number
    MW5096188
    Event Type
    Injury
    Date Received
    August 21, 2020
    Date of Event
    June 17, 2020
    Report Date
    August 19, 2020
    Manufacturer
    CONG TY CO PHAN THIET BI Y TE SHB HANOI
    Product Code
    QKR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACE MASK BY THE MANUFACTURER SHB WAS ADVERTISED THAT IT HELPS PREVENT THE VIRUS AND HAVE THE ANTIBACTERIAL OF 99.99%. THEN I BOUGHT IT FOR MY FRIEND AND USE THEM. THEY ALWAYS USE IT ALL THE TIME UNTIL SOME OF THEM GOT COVID-19. I SUSPECT THIS MASK IS NOT WHAT THEY ADVERTISED AS IT SAID ON THE BOX PREVENT THE USER FROM VIRUSES AS 3 OF MY FRIENDS ARE POSITIVE TO THE COVID-19 AND THEY ONLY USE THIS BRAND OF MASK, AND THE QUALITY OF THE PRODUCTS IS QUESTIONABLE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904577 SHB MEDICAL FACE MASK FACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER II QKR CONG TY CO PHAN THIET BI Y TE SHB HANOI
    904578 SHB MEDICAL FACE MASK FACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER II QKR CONG TY CO PHAN THIET BI Y TE SHB HANOI
    904579 SHB MEDICAL FACE MASK FACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER II QKR CONG TY CO PHAN THIET BI Y TE SHB HANOI

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention