BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1022902 · Received March 28, 2008

    Report

    Report Number
    6000030-2008-01651
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 25, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE HCP ATTEMPTED TO DRAIN A PUMP POCKET SEROMA, UPON ENTRY IT WAS DISCOVERED THAT THE SUTURLESS CATHETER HAD BECOME DISCONNECTED FROM THE PUMP, NOT FROM THE PIN, BUT AT THE SNAP RING. IT WAS ALSO REPORTED THAT THE DOCTOR IS VERY THOROUGH AND ALWAYS CHECKS THE PUMP/CATHETER CONNECTION BEFORE CLOSING THE POCKET BY "TUGGING ON THE CATHETER" TO VERIFY THE CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709SC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| IMPLANTED:| PUMP MODEL# : 863740| PROGRAMMER MODEL 8840| IMPLANTED:| EXPLANTED: