BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPD CATHETER

    MDR report key: 2680494 · Received July 30, 2012

    Report

    Report Number
    MW5026362
    Event Type
    Malfunction
    Date Received
    July 30, 2012
    Report Date
    July 27, 2012
    Manufacturer
    MEDIGROUP, INC
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EXCESSIVE AND INTENSE INTRA-ABDOMINAL INFLAMMATION AFTER CATHETER INSERTION. HAS HAPPENED APPROX 8-10 TIMES, LOST 1 1/2 - 2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPD CATHETER KDJ MEDIGROUP, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other