BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX® MALECOT MODEL DRAIN

    MDR report key: 8662376 · Received June 3, 2019

    Report

    Report Number
    8662376
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    April 27, 2019
    Report Date
    May 7, 2019
    Manufacturer
    C. R. BARD, INC.
    Product Code
    FEW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PROLONGED INTENSIVE CARE UNIT COURSE. HAD A MALECOT PLACED FOR LIQUID STOOL TO PREVENT SKIN BREAKDOWN. BLEEDING NOTED FROM RECTAL TUBE. HAD URGENT SIGMOIDOSCOPY FOR RECTAL ULCER AND VISIBLE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457784 BARDEX® MALECOT MODEL DRAIN CATHETER, MALECOT FEW C. R. BARD, INC. 086034

    Patients

    Seq Age Sex Outcome Treatment
    1 11315 DA Hospitalization| R