BEUDAMED
    FDA Adverse Event Other Summary report: N

    PES, PLUME EVACUATION SYSTEM

    MDR report key: 564160 · Received December 10, 2004

    Report

    Report Number
    564160
    Event Type
    Other
    Date Received
    December 10, 2004
    Date of Event
    November 19, 2004
    Report Date
    December 10, 2004
    Manufacturer
    STERIS CORPORATION
    Product Code
    FYD
    Report Source
    User Facility report
    Reporter Location
    WA, US

    Narratives

    Description of Event or Problem · 1

    STERILE PACKAGE IS DISINTEGRATING.FOLLOW-UP WITH SITE REVEALS THAT TYVEK SEAL IS INTACT, BUT WHEN PACKAGE IS OPENED, A CLEAN BREAK DOES NOT OCCUR - PLASTIC HAS A JAGGED EDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PES, PLUME EVACUATION SYSTEM TUBING, SURGICAL SMOKE EVACUATION FYD STERIS CORPORATION * 44-000468

    Patients

    Seq Age Sex Outcome Treatment
    1 *