BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALECOT CATHETER

    MDR report key: 4034917 · Received August 13, 2014

    Report

    Report Number
    4034917
    Event Type
    Injury
    Date Received
    August 13, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 11, 2014
    Manufacturer
    COOK MEDICAL
    Product Code
    FEW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IS A (B)(6) YEAR OLD MALE WITH A HISTORY OF RECENT BLADDER NECK RECONSTRUCTION ON (B)(6) 2014. HE WAS ADMITTED ON (B)(6) 2014 FOR ENDOSCOPIC EVAL. HE HAD SOME LEAKAGE FROM HIS MIDLINE INCISION. HE WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2014 FOR REMOVAL OF ALL TUBES AND DRAINS THAT WERE PLACED ON (B)(6) 2014. WHEN THE 12 FRENCH MALECOT CATHETER WAS REMOVED THE TIP WAS MISSING. A CYSTOSCOPY WAS DONE AND THE MISSING TIP WAS NOT IN THE BLADDER. A SMALL INCISION WAS MADE AND AN EXPLORATORY LAP WAS PREFORMED TO LOOK FOR THE TIP BETWEEN THE BLADDER AND ABDOMINAL WALL. IT COULD NOT BE LOCATED. AN X-RAY WAS ALSO TAKEN WHICH DID NOT SHOW THE MISSING TIP. IT IS NOT RADIOPAQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483516 MALECOT CATHETER MALECOT CATHETER FEW COOK MEDICAL SILICONE 12 FR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other