BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE PORT VASCULAR SYSTEM

    MDR report key: 84727 · Received July 1, 1996

    Report

    Report Number
    84727
    Event Type
    Injury
    Date Received
    July 1, 1996
    Date of Event
    April 30, 1996
    Report Date
    May 3, 1996
    Manufacturer
    STRATO MEDICAL CORP
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED 4/28/96 FOR PAIN CONTROL, POSS. RECURRANCE. PORT PLACED APPROXIMATELY 6 MONTHS AGO. PORT HAD BEEN USED WITHOUT ANY PROBLEMS. THEY WERE PLANNING TO USE PORT THIS ADMISSION, BUT PT NOTICED PINCHING SENSATION IN LEFT SHOULDER WHEN SHE LAID ON THAT SIDE. HAD CHEST X-RAY WHICH SHOWED THE PORT HAD BECOME DISLODGED AND THERE WAS EVIDENCE OF SEPARATION OF THE CATHETER. ON EVALUATING THE CHEST X-RAY, IT DOES APPEAR THAT HER CATHETER IS FRACTURED AT SITE WHERE IT PASSES BETWEEN THE RIB AND CLAVICLE. 4/30/96, PORT REMOVAL AND RETRIEVAL OF CATH WITH NEW PORT PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PORT VASCULAR SYSTEM Implant INFUSE A PORT LIFE PORT LJT STRATO MEDICAL CORP LPS 7513 R12856

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention