BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNOL FLUIDSHEILD PFR95

    MDR report key: 1953207 · Received January 7, 2011

    Report

    Report Number
    9616096-2011-00001
    Event Type
    Injury
    Date Received
    January 7, 2011
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THE PRODUCT MET ALL MANUFACTURING SPECIFICATIONS AND PASSED FILTRATION TESTING. THE MASK INVOLVED IN THE INCIDENT WAS NOT AVAILABLE FROM THE USER FACILITY AND THEREFORE COULD NOT BE EVALUATED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS. DEVICE NOT RETURNED TO KIMBERLY-CLARK BY THE CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "WHILE FIT TESTING WITH THE (B)(4) AND BITTER SOLUTION FROM 3M THE PERSONNEL FAILED THE TEST THEN WAS RETESTED IMMEDIATELY WHILE WEARING A 3M MASK USING THE 3M BITTER SOLUTION, THE PERSONNEL EXPERIENCED RESPIRATORY DISTRESS AND WAS INTUBATED. EMPLOYEE IS OFF THE VENTILATOR TODAY." KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS RECORD (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNOL FLUIDSHEILD PFR95 N95 MASK FXX KIMBERLY-CLARK HEALTH CARE AM9299B84

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention