BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVAPLUS EXTRA TRACTION - XL

    MDR report key: 2424059 · Received January 20, 2012

    Report

    Report Number
    2083545-2012-00001
    Event Type
    Injury
    Date Received
    January 20, 2012
    Report Date
    December 23, 2011
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    FXP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THIS EVENT IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED. 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. INFORMATION FROM THIS EVENT HAS BEEN CAPTURED IN COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "TWO SEPARATE SLIP/FALL INCIDENTS WERE REPORTED IN (B)(6) IN THE HOSPITAL LAB AND OR. ACCORDING TO A REPORT FROM THE DISTRIBUTOR (B)(4), ONE OF THE EMPLOYEES THAT FELL HAD TO SPEND A NIGHT IN THE HOSPITAL. IT WAS REPORTED THAT THE PRODUCT BEING USED DURING THE INCIDENT DID NOT HAVE ADEQUATE TREAD/GRIP." 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 NOVAPLUS EXTRA TRACTION - XL SHOE COVER FXP KIMBERLY-CLARK HEALTH CARE CA1253003

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization