BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE CAREY-ALZATE-COONS GASTROJEJUNOSTOMY SET

    MDR report key: 6585505 · Received May 23, 2017

    Report

    Report Number
    6585505
    Event Type
    Malfunction
    Date Received
    May 23, 2017
    Date of Event
    April 24, 2017
    Report Date
    May 3, 2017
    Manufacturer
    COOK INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT REPLACEMENT OF G-TUBE BECAUSE THE RED CAP FRACTURED DURING USE AT HOME. SECOND REPORT OF THIS TYPE OF G-TUBE W/ RED CAP BREAKAGE IN A WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365896 ULTRATHANE CAREY-ALZATE-COONS GASTROJEJUNOSTOMY SET TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT COOK INC. G27044 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR