BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLOPLAST URINE CATHETER

    MDR report key: 2596070 · Received May 25, 2012

    Report

    Report Number
    MW5025568
    Event Type
    Malfunction
    Date Received
    May 25, 2012
    Date of Event
    May 24, 2012
    Report Date
    May 25, 2012
    Manufacturer
    COLOPLAST CORP.
    Product Code
    GBM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MOM REPORTS THAT THEY HAVE HAD CONTINUING ISSUES WITH THEIR URINARY CATHETER BALLOONS DEFLATING. SHE STATED THAT SHE WENT TO CHANGE THE CHILD'S DIAPER AND SHE FOUND THE CATHETER WAS COMPLETELY OUT OF THE PT AND THE BALLOON APPEARED TO HAVE BURST. SHE SAID THAT SHE IS CONCERNED THAT THERE MAY STILL BE PIECES OF THE CATHETER IN THE CHILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLOPLAST URINE CATHETER URINARY CATHETER GBM COLOPLAST CORP. AA6110 UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO