BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD N95 DUCK BILL

    MDR report key: 10122880 · Received June 5, 2020

    Report

    Report Number
    10122880
    Event Type
    Malfunction
    Date Received
    June 5, 2020
    Date of Event
    May 11, 2020
    Report Date
    May 12, 2020
    Manufacturer
    O&M HALYARD, INC
    Product Code
    FXX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO EMPLOYEES CHANGED OUT SMALL DUCK BILL MASKS AT 0700. BY 0945, BOTH EMPLOYEES' MASKS HAD BECOME UNUSABLE DUE TO STRAPS SNAPPING OFF OF THE MASK, WITH NORMAL DONNING AND DOFFING. BOTH MASKS FROM THE SAME LOT. HALYARD HEALTH INC., N95 46827, NIOSH TC-84A-7518, SMALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586179 HALYARD N95 DUCK BILL MASK, SURGICAL FXX O&M HALYARD, INC 46827 AM9083812

    Patients

    Seq Age Sex Outcome Treatment
    1