BEUDAMED
    FDA Adverse Event Other Summary report: N

    MALECOT RUSSEL GASTROSTOMY CATHETER

    MDR report key: 492249 · Received October 22, 2003

    Report

    Report Number
    1820334-2003-00185
    Event Type
    Other
    Date Received
    October 22, 2003
    Date of Event
    September 5, 2003
    Report Date
    September 26, 2003
    Manufacturer
    COOK, INC.
    Product Code
    EZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED CEREBRAL HEMORRHAGE IN 2003, AND UNDERWENT THE PEG DUE TO DYSPHAGY AS SEQUELA OF THE CEREBRAL HEMORRHAGE AT A HOSPITAL, WHERE THE DEVICE WAS FIRST PLACED 4 MONTHS EARLIER. APPROXIMATELY 100 DAYS AFTER PLACEMENT, THE CATHETER CAME OUT SPONTANEOUSLY DUE TO THE CLOSURE OF THE MALECOT. THE PHYSICIAN ADVISES THE CATHETER WAS FLUSHED AFTER EACH DRUG ADMINISTRATION. MINOR SWELLING WAS OBSERVED ON THE CATHETER SHAFT, APPROXIMATELY 7CM FROM THE TIP. THE PATIENT UNDERWENT THE SECOND PEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALECOT RUSSEL GASTROSTOMY CATHETER CATHETER EZK COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other