BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGADERM TRANSPARENT DRESSING, PICTURE FRAME STYLE 1616

    MDR report key: 579886 · Received March 7, 2005

    Report

    Report Number
    MW1034834
    Event Type
    Injury
    Date Received
    March 7, 2005
    Date of Event
    September 1, 2004
    Report Date
    March 7, 2005
    Manufacturer
    3M
    Product Code
    FRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INCREASED INCIDENCE OF NOSOCOMIAL FUNGEMIA RELATED TO CENTRAL VENOUS CATHETERS. SUBSEQUENTLY FOUND THAT LINE RELATED INFECTION OF ALL CAUSES INCREASED. THERE WERE 8 EXCESS CASES OF CANDIDEMIA RELATED TO LINES FROM 8/15/2004 - 10/13/2004. RATE OF LINE RELATED BSI WENT FROM A BASELINE OF 0.66/1000 PT DAYS TO A PEAK OF 2.45 -95% CI 1.1-3.7- IN SEPT. 2004. THE INCREASE IN INFECTIONS CORRESPONDED TO INTRODUCTION OF A NEW CENTRAL CATHETER DRESSING. AFTER REMOVING THE SUSPECTED PRODUCT, RATE HAS FALLEN BACK TO 1.0 -CI0.51-2.6-CASES PER 1000 PT DAYS IN 1/2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEGADERM TRANSPARENT DRESSING, PICTURE FRAME STYLE 1616 CENTRAL LINE DRESSING FRO 3M 1616 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| L| R