BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX - LUBRICATED

    MDR report key: 106039 · Received July 1, 1997

    Report

    Report Number
    106039
    Event Type
    Malfunction
    Date Received
    July 1, 1997
    Date of Event
    June 27, 1997
    Report Date
    June 30, 1997
    Manufacturer
    C.R. BARD, INC BARD UROLOGICAL DIVISION
    Product Code
    KOB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT AN ANTERIOR AND POSTERIOR REPAIR, STAMEY URETHROPEXY AND PLACEMENT OF A SUPRAPUBIC CATHETER ON 6/24/97. THREE DAYS POSTOP, PT LYING IN BED, WHEN SUPRAPUBIC CATHETER "FELL OUT." URINE BEGAN LEAKING PROFUSELY FROM SUPRAPUBIC SITE. CATHETER HAD BEEN CLAMPED. BALLOON APPEARED RUPTURED. URETHRAL FOLEY CATHETER PLACED. NOW NEEDS TO LEARN SELF-CATHETERIZATION AND CARE OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDEX - LUBRICATED Implant SUPRAPUBIC CATHETER KOB C.R. BARD, INC BARD UROLOGICAL DIVISION 12 FR. - 5CC D165L12

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other