BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASK

    MDR report key: 10325749 · Received July 24, 2020

    Report

    Report Number
    MW5095705
    Event Type
    Injury
    Date Received
    July 24, 2020
    Date of Event
    May 18, 2020
    Report Date
    July 23, 2020
    Manufacturer
    PAC-DENT, INC.
    Product Code
    MSH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MEDICAL MASKS FROM PACDENT, INC ARE NOT LABELED AS MEDICAL MASKS, WITH ASTM LEVEL 1-3, BUT THE ACTUAL PRODUCTS ARE OF LOW QUALITY, AND SEVERAL PATIENTS WERE TESTED POSITIVE AFTER WEARING THE MASKS. THE COMPANY CLAIMED THEIR MASKS ARE REGISTERED WITH FDA, BUT AFTER CHECKING WITH FDA , THE COMPANY INTENDED TO FALSELY USED THE REGISTRATION PRODUCT CODE MSH, WITHOUT THE FDA PREMARKET REGISTRATION. FDA SAFETY REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783045 MASK RESPIRATOR, SURGICAL MSH PAC-DENT, INC. ASTM LEVEL 1-3, N95 MASK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| S