BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSEAL SURGICAL SEALANT

    MDR report key: 534278 · Received March 16, 2004

    Report

    Report Number
    2953731-2004-00001
    Event Type
    Malfunction
    Date Received
    March 16, 2004
    Date of Event
    January 1, 2004
    Report Date
    February 16, 2004
    Manufacturer
    COHESION TECHNOLOGIES, INC.
    Product Code
    NBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE THE SCRUB NURSE WAS TIGHTENING THE HOUSING ON THE SYRINGES PRIOR TO MIXING, THE HOUSING CRACKED AND FLUID LEAKED OUT OF THE SYRINGE RENDERING THE KIT UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSEAL SURGICAL SEALANT SEALANT NBE COHESION TECHNOLOGIES, INC. FXP070 C05010021

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention