BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMASK PREMIUM FACE MASKS ASTM-2 AND ASTM-3

    MDR report key: 10179397 · Received June 19, 2020

    Report

    Report Number
    MW5095125
    Event Type
    Malfunction
    Date Received
    June 19, 2020
    Date of Event
    June 8, 2020
    Report Date
    June 17, 2020
    Manufacturer
    PAC-DENT, INC.
    Product Code
    FXX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE MEDICAL MASK WAS LABELED AS A MEDICAL MASK MEETING ASTM LEVEL 2 AND ASTM LEVEL 3 STANDARD, BUT THE QUALITY OF THE PRODUCTS WAS NOT AS DESCRIBED, THEY WERE PRODUCTS OF THE LOWER QUALITY. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637540 IMASK PREMIUM FACE MASKS ASTM-2 AND ASTM-3 MASK, SURGICAL FXX PAC-DENT, INC. IMASK

    Patients

    Seq Age Sex Outcome Treatment
    1