BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLASSIC ADULT COILED PD CATHETER

    MDR report key: 2061721 · Received April 13, 2011

    Report

    Report Number
    MW5020283
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 6, 2011
    Report Date
    April 13, 2011
    Manufacturer
    MEDIGROUP, INC
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PD CATHETER HAD A PIN SIZE HOLE. REQUIRED REPLACEMENT OF ADAPTER AND NEW TRANSFER SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLASSIC ADULT COILED PD CATHETER PEDIATRIC PERITONEAL CATHETER FJS MEDIGROUP, INC CF 5260

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR