BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOSEAL

    MDR report key: 2162046 · Received July 6, 2011

    Report

    Report Number
    2162046
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FLOSEAL HEMOSTATIC MATRIX PRODUCT DID NOT MIX APPROPRIATELY. IT WAS DIFFICULT TO MIX (PRODUCT FELT/APPEARED TO BE TOO THICK) AND THE PRODUCT HAD AN ODD COLOR (IT WAS BROWN INSTEAD OF THE EXPECTED YELLOWISH COLOR). THE PRODUCT WAS REMOVED FROM THE FIELD AND NEVER APPLIED TO THE PATIENT'S SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOSEAL AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE CORPORATION * HA110324

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR