BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TRIO

    MDR report key: 1913255 · Received November 23, 2010

    Report

    Report Number
    1913255
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INNER CASING OF ENSEAL PEELED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL TRIO TISSUE SEALING DEVICE GEI ETHICON ENDO-SURGERY ETRIO-335H G4TV81

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR NO OTHER THERAPIES