BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOUNDSTAT HEMOSTATIC AGENT

    MDR report key: 1431528 · Received July 22, 2009

    Report

    Report Number
    MW5012219
    Event Type
    Malfunction
    Date Received
    July 22, 2009
    Report Date
    July 22, 2009
    Manufacturer
    TRAUMACURE, INC.
    Product Code
    LMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PERMANENT SUSPENSION OF WOUNDSTAT - WS USE BY MEDICAL PERSONNEL DUE TO SAFETY CONCERNS CONFIRMED BY THE US ARMY INSTITUTE OF SURGICAL RESEARCH -USAISR-. THE RISK INHERENT IN WS USE OUTWEIGHS ITS BENEFIT AS A BACK-UP HEMOSTATIC AGENT TO COMBAT GAUZE -CG- FOR 68W COMBAT MEDICS. CG REMAINS THE RECOMMENDED HEMOSTATIC AGENT FOR CURRENT COMBAT OPERATIONS. THE POINT OF CONTACT IS THE DIRECTOR OF HEALTH POLICY AND SERVICES, OFFICE OF THE SURGEON GENERAL, COMMERCIAL, DSN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOUNDSTAT HEMOSTATIC AGENT NONE LMF TRAUMACURE, INC. TC1001-064 ALL

    Patients

    Seq Age Sex Outcome Treatment
    1