BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FITUSA MANUFACTURING EARLOOP STYLE BASIC FACEMASK

    MDR report key: 10051270 · Received May 12, 2020

    Report

    Report Number
    MW5094457
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    May 6, 2020
    Report Date
    May 8, 2020
    Manufacturer
    UNK
    Product Code
    MSH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FITUSA MANUFACTURING IS SELLING POORLY-MADE FACE MASKS AND ADVERTISING THAT THE MASKS HAVE AN FDA CLASSIFICATION. "CLASSIFICATION REGULATION: 21 CFR 868.5450; DEVICE TYPE: HUMIDIFIER, RESPIRATORY MASK; PRODUCT CODE: OBN." THE INFORMATION IS FALSE. THE MASKS ARE SINGLE LAYER, HIGHLY-PERMEABLE MASKS THAT SERVE LITTLE PURPOSE TO PREVENT THE SPREAD OF COVID-19. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509799 FITUSA MANUFACTURING EARLOOP STYLE BASIC FACEMASK RESPIRATOR, SURGICAL MSH UNK FACEMASK

    Patients

    Seq Age Sex Outcome Treatment
    1