BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSEAL SURGICAL SEALANT

    MDR report key: 1582943 · Received January 21, 2010

    Report

    Report Number
    2954761-2010-00003
    Event Type
    Malfunction
    Date Received
    January 21, 2010
    Report Date
    January 13, 2010
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    NBE
    PMA / PMN Number
    P030039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF A PARTICLE WAS TO BE LEFT IN-SITU THE WORSE CASE SCENARIO WOULD LEAD TO LOCALIZED FOREIGN BODY REACTION. THE SAMPLE HAS NOT YET BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE IT IS RECEIVED AND EVALUATED.

    Description of Event or Problem · 1

    A BLACK PARTICLE WAS SEEN IN THE SOLUTION AFTER RECONSTITUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSEAL SURGICAL SEALANT SEALANT,POLYMERIZING NBE BAXTER HEALTHCARE - HAYWARD HA091045

    Patients

    Seq Age Sex Outcome Treatment
    1