BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® MALECOT MODEL DRAIN

    MDR report key: 7078471 · Received December 4, 2017

    Report

    Report Number
    7078471
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    November 6, 2016
    Report Date
    December 1, 2017
    Manufacturer
    C. R. BARD, INC.
    Product Code
    FEW
    UDI-DI
    00801741023927
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RECTAL TUBE INSERTED ON ADMISSION (NON-BALLOONED) AND REPLACED DURING ADMISSION. NEEDED AS WAS UNABLE TO HAVE NASOGASTRIC TUBE RELATED TO EPISTAXIS. RECTAL TUBE NEEDED FOR LACTULOSE ADMINISTRATION. PATIENT SUFFERED LOWER RECTAL BLEED FROM A RECTAL ULCER REQUIRING CLIPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857739 BARDEX® MALECOT MODEL DRAIN CATHETER, MALECOT FEW C. R. BARD, INC. 086032 NGBP2484 00801741023927

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other DIALYSIS| NO OTHER DEVICES IN USE| OTHER, PATIENT RECEIVING RECTAL LACTULOSE THROUGH