BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSS HIDE-A-PORT LOW PROFILE GASTROSTOMY KIT

    MDR report key: 522795 · Received April 29, 2004

    Report

    Report Number
    1528738-2004-00020
    Event Type
    Injury
    Date Received
    April 29, 2004
    Date of Event
    March 29, 2004
    Report Date
    April 5, 2004
    Manufacturer
    ROSS PRODUCTS DIVISION/ABBOTT LABORATORIES
    Product Code
    KNT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER CALLED AFTER HRS TO REPORT THAT THEY NEEDED A 24 FR G-TUBE FOR THE PT, OR THE PT WOULD GO INTO SEIZURES AND DIE. REPORTER WAS ADVISED TO TAKE THE PT TO THE E.R. AT THE E.R., THE DEVICE WAS REPLACED WITH A STANDARD REPLACEMENT G-TUBE. BLEEDING AT THE SITE WAS REPORTED. THE SITE WAS CAUTERIZED WITH SILVER NITRATE. ONE PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROSS HIDE-A-PORT LOW PROFILE GASTROSTOMY KIT 78 KNT TUBES, GASTROINTESTINAL AND ACCESSORIES KNT ROSS PRODUCTS DIVISION/ABBOTT LABORATORIES 55715 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention