BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA CATHETER

    MDR report key: 795722 · Received December 13, 2006

    Report

    Report Number
    6000030-2006-02211
    Event Type
    Injury
    Date Received
    December 13, 2006
    Report Date
    November 27, 2006
    Manufacturer
    RICE CREK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    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 THAT THE PUMP WAS REPLACED DUE TO A MFR'S RECALL. DURING REPLACEMENT OF THE DEVICE, IT WAS NOTED THAT THERE WAS A FRACTURE WHERE THE CATHETER CONNECTS TO THE PUMP. THE PT WAS RECEIVING LIORESAL 825 MCG/DAY PRIOR TO SURGERY. THE PT WAS NOT EXPERIENCING ANY SYMPTOMS, HOWEVER, IT IS UNK HOW MUCH DRUG THE PT WAS RECEIVING WITH RESPECT TO THE FRACTURE. THE PT EXPERIENCED POSTOP COMPLICATIONS BUT HAS RECOVERED WITHOUT SEQUELA AND THERAPY HAS IMPROVED WITH THE NEW PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATHETER LKK LKK RICE CREK MFG 8709 L74358

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R EXPLANTED:| IMPLANTED:| PUMP MODEL#: 862718