BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD FLUIDSHIELD 3 N95

    MDR report key: 10378719 · Received August 6, 2020

    Report

    Report Number
    MW5095935
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Report Date
    August 5, 2020
    Manufacturer
    O & M HALYARD, INC.
    Product Code
    KHA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEWLY REPROCESSED N-95 HALYARD REGULAR DUCKBILL THAT HAS BEEN AIRED FOR A WEEK CONTINUES TO SMELL OF BURNT PLASTIC. WHEN USED, STAFF DEVELOPED ASTHMA EXACERBATION, DIFFICULTY OF BREATHING, AND CAUSING NOSE/SINUS BURN SENSATION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841294 HALYARD FLUIDSHIELD 3 N95 N95 MASK, SURGICAL KHA O & M HALYARD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR