BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGNICARE STOOL MANAGEMENT SYSTEM

    MDR report key: 1567715 · Received December 21, 2009

    Report

    Report Number
    1567715
    Event Type
    Malfunction
    Date Received
    December 21, 2009
    Date of Event
    December 21, 2009
    Report Date
    December 21, 2009
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    MIP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    FLUSH PORT OF DIGNICARE SPLIT OFF WHILE FLUSHING. NOW INOPERABLE. NEW DIGNICARE PLACED.PIECE THAT BROKE OFF WAS SAVED. THE REST OF THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGNICARE STOOL MANAGEMENT SYSTEM STOOL MANAGEMENT SYSTEM MIP BARD MEDICAL DIVISION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR