BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTASEPT WITH 2% CHG ANTISEPTIC SOLUTION

    MDR report key: 1695603 · Received May 18, 2010

    Report

    Report Number
    MW5015988
    Event Type
    Injury
    Date Received
    May 18, 2010
    Manufacturer
    MEDICAL ACTION INDUSTRIES, INC
    Product Code
    LRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE HAVE NOTED IN OUR CV UNIT THAT PTS ARE DEVELOPING SKIN BREAKDOWN, REDNESS AND BLISTERING UNDER THE TEGADERM. APPROXIMATELY 10 CASES. THE COMPANY HAS BEEN CALLED AND WE HAVE SUSPENDED USE IN OUR CV DEPT. DIAGNOSIS OR REASON FOR USE: STERILE DRESSING FOR CENTRAL LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTASEPT WITH 2% CHG ANTISEPTIC SOLUTION ANTISEPTIC SOLUTION LRS MEDICAL ACTION INDUSTRIES, INC 081011
    2 3M TEGADERM DRESSING DRESSING NAD *

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability