BEUDAMED
    FDA Adverse Event Death Summary report: N

    PC PALINDROME 23/40 KIT W/SLOT

    MDR report key: 1033016 · Received April 22, 2008

    Report

    Report Number
    1317749-2008-00065
    Event Type
    Death
    Date Received
    April 22, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 25, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTH CARE/KENDALL ON 03/21/08 THAT A CUSTOMER HAD A PROBLEM WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTED THAT THE PT HAD THE CATHETER IN FOR 3 MONTHS AND THEN DURING DIALYSIS TREATMENT ONE DAY THE CATHETER MIGRATED OUT OF THE TUNNEL. A NEW CATHETER WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PC PALINDROME 23/40 KIT W/SLOT DIALYSIS CATHETER MPB TYCO HEALTHCARE/KENDALL 8888145059 733818

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK