BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMBERLY-CLARK® N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK

    MDR report key: 10017185 · Received May 1, 2020

    Report

    Report Number
    10017185
    Event Type
    Malfunction
    Date Received
    May 1, 2020
    Date of Event
    April 27, 2020
    Report Date
    April 28, 2020
    Manufacturer
    KIMBERLY-CLARK GLOBAL SALES, LLC
    Product Code
    MSH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RN WAS BEING FIT TESTED BY EDUCATOR AND WHEN SHE WENT TO PUT ON A SMALL N95 MASK, ONE OF THE STRAPS BROKE. MASK- KIMBERLY CLARK CORP, PFR95, N95 PARTICULATE RESPIRATOR, NIOSH (B)(4) SMALL. MANUFACTURER RESPONSE FOR PROTECTIVE MASK, N-95 MASK (SMALL) (PER SITE REPORTER). UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480930 KIMBERLY-CLARK® N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK RESPIRATOR,SURGICAL MSH KIMBERLY-CLARK GLOBAL SALES, LLC 46867 NIOSH TC-84A-7520

    Patients

    Seq Age Sex Outcome Treatment
    1