BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N95 PARTICULATE RESPIRATOR

    MDR report key: 10065037 · Received May 15, 2020

    Report

    Report Number
    MW5094522
    Event Type
    Malfunction
    Date Received
    May 15, 2020
    Date of Event
    May 13, 2020
    Report Date
    May 13, 2020
    Manufacturer
    FOSHAN FLYING MEDICAL PRODUCTS CO., LTD.
    Product Code
    MSH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LIED ABOUT FDA APPROVAL; ON (B)(6) 2020 I PURCHASED 3 PACKS (2 IN EACH PACK) OF N95 PARTICULATE RESPIRATOR MASKS FROM (B)(6) AT THIS WEBSITE: (B)(6). MY ORDER NUMBER IS (B)(6). THEIR SITE SAID THE MASK WAS FDA REGISTERED AND A (B)(6) SEARCH SAID: "(B)(6). N95 RESPIRATOR MASK REUSABLE, (FDA APPROVED) AND FULL-FACE SAFETY ANTI-SPLASH PROTECTIVE SHIELD ARE NOW AVAILABLE AT OUR ONLINE STORE. INVENTORY IS CURRENTLY VERY LIMITED. PRIORITIZED FOR OLDER ADULTS AND HEALTH WORKERS ON THE FRONTLINES RESPONDING TO COVID-19." I RECEIVED THE MASKS ON 5/8/2020. UPON INSPECTION I NOTICED THAT THE PACKAGE DID NOT LIST WHO MANUFACTURED IT OR WHERE IT WAS MANUFACTURED. THE "FDA" APPROVAL WAS WRITTEN LARGER THAN (B)(6). I OPENED 1 PACK AND THE MASKS HAVE MANY HOLES IN THEM WITH A SEE-THRU EXTREMELY THIN BARRIER, I FELT SOMETHING WAS WRONG AND I CONTACTED THE COMPANY. (B)(4) SAID FOSHAN FLYING MEDICAL PRODUCTS CO. LTD MADE THE MASKS. ON (B)(6) 2020 I CALLED THE FDA AT (B)(6) AND SPOKE TO (B)(6) WHO CHECKED AND SAID FOSHAN FLYING MEDICAL PRODUCTS CO. LTD IS NOT ON THE FDA EUA APPROVED LIST, IT IS NOT ON THE NIOSH APPROVED LIST, AND IT IS NOT ON THE (CDC) NON NIOSH EM LIST. (B)(6) SAID THE MASKS ARE NOT FDA APPROVED AND I SHOULD MAKE THIS REPORT TO THE FDA. I PURCHASED THESE 6 MASKS COSTING (B)(6) BECAUSE (B)(6) SAID THEY WERE FDA APPROVED AND THEY ARE NOT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524783 N95 PARTICULATE RESPIRATOR RESPIRATOR, SURGICAL MSH FOSHAN FLYING MEDICAL PRODUCTS CO., LTD. M63783
    524785 N95 PARTICULATE RESPIRATOR RESPIRATOR, SURGICAL MSH FOSHAN FLYING MEDICAL PRODUCTS CO., LTD. M63783
    524786 N95 PARTICULATE RESPIRATOR RESPIRATOR, SURGICAL MSH FOSHAN FLYING MEDICAL PRODUCTS CO., LTD. M63783
    524787 N95 PARTICULATE RESPIRATOR RESPIRATOR, SURGICAL MSH FOSHAN FLYING MEDICAL PRODUCTS CO., LTD. M63783
    524788 N95 PARTICULATE RESPIRATOR RESPIRATOR, SURGICAL MSH FOSHAN FLYING MEDICAL PRODUCTS CO., LTD. M63783
    524789 N95 PARTICULATE RESPIRATOR RESPIRATOR, SURGICAL MSH FOSHAN FLYING MEDICAL PRODUCTS CO., LTD. M63783

    Patients

    Seq Age Sex Outcome Treatment
    1 Other