BEUDAMED
    FDA Adverse Event Summary report: N

    TRUWAVE

    MDR report key: 4180026 · Received September 18, 2014

    Report

    Report Number
    4180026
    Date Received
    September 18, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 18, 2014
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DXO
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    RN FOUND A LONG HAIR IN UNOPENED STERILE PACKAGE PRIOR TO USE ON PATIENT. NO OTHER KNOWN ISSUES WITH SAME PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579655 TRUWAVE TRUWAVE DXO EDWARDS LIFESCIENCES LLC * 59677497

    Patients

    Seq Age Sex Outcome Treatment
    1 *