BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PC PALINDROME 19/36 KIT W/SLOT

    MDR report key: 1910842 · Received November 23, 2010

    Report

    Report Number
    1317749-2010-00319
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    August 1, 2010
    Report Date
    November 11, 2010
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE DOCTOR FOUND LEAKAGE OF THE CATHETER AFTER SURGERY. THEN THEY REMOVED IT AND REPLACED. UNK WHERE LEAKAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PC PALINDROME 19/36 KIT W/SLOT HEMODIALYSIS CATHETER MPB COVIDIEN 8888145058 906963

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK