BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N95 FACE MASKS

    MDR report key: 12460501 · Received September 10, 2021

    Report

    Report Number
    MW5103859
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    September 8, 2021
    Report Date
    September 8, 2021
    Manufacturer
    HSM MED SUPPLY LLC
    Product Code
    QKR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I BOUGHT A PACKAGE OF N95 MASKS, ONLINE, FROM A COMPANY IN (B)(6) NAMED (B)(6). AFTER OPENING THEM, I NOTICE THERE IS NOT ANY NIOSH IDENTIFYING PRINT ON THE MASK ON IN THE PACKAGE. I FEEL THAT THEY MAY BE SELLING AN UNSAFE PRODUCT TO THE PUBLIC. THE ADDRESS IS (B)(6), THE MANUFACTURER IS HSM MEDICAL SUPPLY, LLC, (B)(4). THIS HAS CONCERNED ME ENOUGH TO WRITE AND I HOPE SOMEONE WILL HAVE TIME TO CHECK THEM OUT. THANK YOU. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354832 N95 FACE MASKS FACE MASK PER ENFORCEMENT POLICY FOR FACE MASKS AND RESPIRATORS DURING THE DECLA QKR HSM MED SUPPLY LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR