BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASKS

    MDR report key: 10634786 · Received October 6, 2020

    Report

    Report Number
    10634786
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    July 14, 2020
    Report Date
    September 23, 2020
    Manufacturer
    XIANTAO ZHIBO NONWOVEN PRODUCTS CO.,LTD
    Product Code
    FXX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BLUE SURGICAL MASKS WITH EAR LOOP: STAFF STATES THERE WERE TINY PIECES OF FIBER LOOSE ON THE INSIDE OF THE MASK THAT WOULD GET INTO HER MOUTH WHEN SPEAKING AND WAS ACTUALLY ABLE TO WRAP A PIECE OF FIBER AROUND HER TONGUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101987 MASKS MASK, SURGICAL FXX XIANTAO ZHIBO NONWOVEN PRODUCTS CO.,LTD 20200318 20200318

    Patients

    Seq Age Sex Outcome Treatment
    1