BEUDAMED
    FDA Adverse Event Other Summary report: N

    CATHETER, FOLEY, 16FR 5CC, SILI-

    MDR report key: 2003109 · Received January 31, 2011

    Report

    Report Number
    1417592-2011-00003
    Event Type
    Other
    Date Received
    January 31, 2011
    Date of Event
    January 2, 2011
    Report Date
    January 31, 2011
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE FACILITY WAS GOING TO REMOVE THE CATHETER AND THE BALLOON WOULD NOT DEFLATE. WHILE REPOSITIONING THE PT, THE CATHETER FELL OUT AND THE BALLOON STAYED IN. SOME BLEEDING WAS NOTED. HE WAS TRANSPORTED TO THE HOSP AND WAS DISCHARGED THE FOLLOWING DAY WITH A NEW FOLEY. IT IS NOT KNOWN WHAT MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE SAMPLE WAS NOT RETAINED FOR EVAL. NO TRENDS EXIST FOR THIS ISSUE WITH THIS PRODUCT. A ROOT CAUSE HAS NOT BEEN DETERMINED. HOWEVER, DUE TO THE REPORT THAT THE PT WAS SENT TO THE HOSP TO REMOVE THE BALLOON, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    THE CATHETER FELL OUT OF THE PT AND THE BALLOON STAYED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER, FOLEY, 16FR 5CC, SILI- NONE KOD MEDLINE INDUSTRIES, INC. DYND11756 1002020254

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention