BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3PE-X127 NIOSH N95

    MDR report key: 12406711 · Received August 31, 2021

    Report

    Report Number
    MW5103639
    Event Type
    Malfunction
    Date Received
    August 31, 2021
    Date of Event
    August 29, 2021
    Report Date
    August 29, 2021
    Manufacturer
    PACIFIC PPE CORPORATION
    Product Code
    QKU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INHALED NIOSH N95 MASK PARTICLES; I PUT ON ONE OF THESE NIOSH N95 MASKS, AND BREATHED IN SOMETHING THAT MADE ME CHOKE AND GAP. I TOOK THE MASK OFF AND COUGHED OUT ABOUT 3 ROUND, SINGLE-LAYER HOLE PUNCHES OF MASK MATERIAL. NOT SURE IF ONE IS STILL IN MY THROAT (OR LUNGS). I FOUND ANOTHER 2 UPON EXAMINING THE MASK. I CHECKED THE REST OF THE BOX OF 25 AND FOUND 2 MORE WITH LOOSE HOLE PUNCHES INSIDE. I TOOK PICTURES AND SET THESE ASIDE IF NEEDED. WE HAD USED A HANDFUL WITHOUT INCIDENT BEFORE TODAY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287076 3PE-X127 NIOSH N95 NON-NIOSH-APPROVED DISPOSABLE FILTERING FACEPIECE RESPIRATORS (FFRS) QKU PACIFIC PPE CORPORATION TC-84A-9278 X041221D
    1287083 3PE-X127 NIOSH N95 NON-NIOSH-APPROVED DISPOSABLE FILTERING FACEPIECE RESPIRATORS (FFRS) QKU PACIFIC PPE CORPORATION TC-84A-9278 X041221D
    1287084 3PE-X127 NIOSH N95 NON-NIOSH-APPROVED DISPOSABLE FILTERING FACEPIECE RESPIRATORS (FFRS) QKU PACIFIC PPE CORPORATION TC-84A-9278 X041221D
    1287087 3PE-X127 NIOSH N95 NON-NIOSH-APPROVED DISPOSABLE FILTERING FACEPIECE RESPIRATORS (FFRS) QKU PACIFIC PPE CORPORATION TC-84A-9278 X041221D
    1287088 3PE-X127 NIOSH N95 NON-NIOSH-APPROVED DISPOSABLE FILTERING FACEPIECE RESPIRATORS (FFRS) QKU PACIFIC PPE CORPORATION TC-84A-9278 X041221D

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other