BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 571589 · Received February 7, 2005

    Report

    Report Number
    6000030-2005-00210
    Event Type
    Injury
    Date Received
    February 7, 2005
    Date of Event
    September 10, 2004
    Report Date
    February 4, 2005
    Manufacturer
    RICE CREK MFG
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THE PT HAD SALINE IN THE PUMP AT THE TIME OF EXPLANT DUE TO NOT USING. A BROKEN CATHETER WAS NOTED AT THE TIME OF THE EXPLANT. "A PORTION OF THE CATHETER REMAINS IN THE SUBARACHNOID SPACE. THE PT HAD NECTROTIC TISSUE DEEP ALONG THE PARASPINOUS MUSCLES WHERE PART OF THE CATHETER WAS. SURGERY WAS CONSULTED AND WOUND WAS LEFT TO HEAL BY SECONDARY INTENT WITH HOME HEALTH FOLLOWING." THE HCP HAD NO INFO ON THE PT OUTCOME AS "PT LOST TO FOLLOW UP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATH LKK RICE CREK MFG 8703W L60552

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization PUMP:MODEL# 862718, IMP: 1999| EXP: 2004.