BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURESTRAP

    MDR report key: 3922719 · Received June 24, 2014

    Report

    Report Number
    3922719
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN USING THE ETHICON SECURE STRAP 5MM ABSORABLE STRAP FIXATION DEVICE NONE OF THE SYNETHIC ABSORABLE STRAPS WOULD PENETRATE THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368114 SECURESTRAP STAPLE, IMPLANTABLE GDW ETHICON INC. * HCUO11

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR