BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMBERLY-CLARK® FLUIDSHIELD¿ PFR95¿ RESPIRATOR AND SURGICAL MASK

    MDR report key: 9980935 · Received April 21, 2020

    Report

    Report Number
    9980935
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    March 5, 2020
    Report Date
    March 18, 2020
    Manufacturer
    KIMBERLY-CLARK GLOBAL SALES, LLC
    Product Code
    MSH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CNA WENT TO PUT N95 RESPIRATOR ON AND STRAPS BROKE. SHE ATTEMPTED TO USE ANOTHER N95 RESPIRATOR AND THE STRAPS BROKE ON THAT ONE AS WELL. BROUGHT MASKS IN AND HEAD STRAPS NOTED TO BE FRAGILE AND EASILY RIPPED. KIMBERLY CLARK CORP (REGULAR DUCKBILL MASK) PFR95 N95 PARTICULATE RESPIRATOR NIOSH TC-84A-0010 REGULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447348 KIMBERLY-CLARK® FLUIDSHIELD¿ PFR95¿ RESPIRATOR AND SURGICAL MASK RESPIRATOR,SURGICAL MSH KIMBERLY-CLARK GLOBAL SALES, LLC 46767 TC-84A-0010

    Patients

    Seq Age Sex Outcome Treatment
    1