BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOPE HEALTH SUPPLY BLACK KN95 MASKS

    MDR report key: 13445793 · Received February 2, 2022

    Report

    Report Number
    MW5107188
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    January 5, 2022
    Report Date
    January 31, 2022
    Manufacturer
    HOPE HEALTH SUPPLY / BUKREIN NINGBO IMP&EXP CO., LTD
    Product Code
    QKU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IF (B)(6) KN 95 MASKS WERE ON YOUR APPROVED LIST, THE COMPANY SHOULD BE IMMEDIATELY REMOVED. THE SWITCHED THE MANUFACTURER OF THE PRODUCT AND IT IS NOW THINNER, DIFFERENT SIZES COME IN THE SAME PACK OF FIVE, HAVE AN ODOR, DON'T FIT TIGHT. COMPANY HAS NO PHONE AND DOES NOT REPLY TO EMAILS. MASK PURCHASED BEFORE SWITCH WERE VERY GOOD. THESE ARE GARBAGE. THEY ADVERTISE EVERYWHERE AND ARE PROBABLY ONE OF THE TOP SUPPLIERS OF THESE MASKS FROM (B)(6). THANK YOU. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838382 HOPE HEALTH SUPPLY BLACK KN95 MASKS NON-NIOSH-APPROVED DISPOSABLE FILTERING FACEPIECE RESPIRATORS (FFRS) QKU HOPE HEALTH SUPPLY / BUKREIN NINGBO IMP&EXP CO., LTD
    946230 HOPE HEALTH SUPPLY BLACK KN95 MASKS NON-NIOSH-APPROVED DISPOSABLE FILTERING FACEPIECE RESPIRATORS (FFRS) QKU HOPE HEALTH SUPPLY / BUKREIN NINGBO IMP&EXP CO., LTD
    946231 HOPE HEALTH SUPPLY BLACK KN95 MASKS NON-NIOSH-APPROVED DISPOSABLE FILTERING FACEPIECE RESPIRATORS (FFRS) QKU HOPE HEALTH SUPPLY / BUKREIN NINGBO IMP&EXP CO., LTD
    946232 HOPE HEALTH SUPPLY BLACK KN95 MASKS NON-NIOSH-APPROVED DISPOSABLE FILTERING FACEPIECE RESPIRATORS (FFRS) QKU HOPE HEALTH SUPPLY / BUKREIN NINGBO IMP&EXP CO., LTD
    946233 HOPE HEALTH SUPPLY BLACK KN95 MASKS NON-NIOSH-APPROVED DISPOSABLE FILTERING FACEPIECE RESPIRATORS (FFRS) QKU HOPE HEALTH SUPPLY / BUKREIN NINGBO IMP&EXP CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male