BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOSEAL HEMOSTATIC MATRIX

    MDR report key: 1971155 · Received January 20, 2011

    Report

    Report Number
    1971155
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 20, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    WHEN THE TWO MIXING SYRINGES WERE PUT TOGETHER THE FLUID LEAKED OUT. UPON INSPECTION IT WAS DISCOVERED THAT ONE OF THE SYRINGES WAS CRACKED. THE SYRINGE THAT CRACKED WAS THE ONE THAT WAS BRANDED "FLOSEAL." THE CRACK WAS LOCATED AT THE NECK OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOSEAL HEMOSTATIC MATRIX AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE CORPORATION * HA100544

    Patients

    Seq Age Sex Outcome Treatment
    1 *