BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROSHONG CATHETER

    MDR report key: 234979 · Received August 4, 1999

    Report

    Report Number
    1720496-1999-00234
    Event Type
    Injury
    Date Received
    August 4, 1999
    Report Date
    July 1, 1999
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    CATHETER PLACED 1996 FOR TPN. REMOVED 1996. CUFF WAS LEFT IN. 3 DAYS LATER, PT CALLED DR & SAID HER CHEST WAS SORE & INFECTED. COMPRESS APPLIED AND SORENESS LEFT. 07/22/96, FOREIGN BODY IN UPPER CHEST FOUND IN MAMMOGRAM. TURNED OUT TO BE CUFF. CUFF SURGICALLY REMOVED 1996 & CAUSED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG CATHETER Implant LONG TERM INTRAVASCULAR CATHETER DQO BARD ACCESS SYSTEMS 7726950 36IF0382

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention