BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD MALECOT DRAIN

    MDR report key: 507102 · Received January 15, 2004

    Report

    Report Number
    1018233-2004-00001
    Event Type
    Injury
    Date Received
    January 15, 2004
    Date of Event
    December 8, 2003
    Report Date
    January 15, 2004
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY PATIENT, SUPRAPUBIC TUBE REPORTEDLY SPLIT CAUSING LEAKAGE AND SUBSEQUENT SURGICAL REPLACEMENT. PATIENT HAD SURGERY FOR URETHRAL STRICTURE AND PLACEMENT OF SUPRAPUBIC TUBE IN 11/2003. THREE WEEKS LATER, PATIENT EXPERIENCED PAIN, BLOCKAGE AND LEAKAGE AT STOMA. PATIENT WENT TO THE E.R. AND HAD SURGERY THE NEXT DAY, TO REMOVE AND REPLACE SUPRAPUBIC TUBE WITH AN ALL-SILICONE FOLEY CATHETER. ACCORDING TO THE DOCTOR'S REPORT, THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. THE TUBE WAS DISCARDED BY THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD MALECOT DRAIN MALECOT DRAIN FEW C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention