BEUDAMED
    FDA Adverse Event Other Summary report: N

    KIMBERLY-CLARK PEG

    MDR report key: 608228 · Received May 27, 2005

    Report

    Report Number
    3031042-2005-00030
    Event Type
    Other
    Date Received
    May 27, 2005
    Date of Event
    April 14, 2005
    Report Date
    May 27, 2005
    Manufacturer
    BALLARD MEDICAL
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REG GASTOSTOMY TUBE SNAPPED APART WHEN THE PHYSICIAN TRIED TO REMOVED THE TUBE USING THE TRACTION METHOD. THE INTERNAL RETENTION DOME WAS LEFT INSIDE THE PATIENT'S STOMACH AND THERE WAS NO ATTEMPT TO RETRIEVE THE PART. IT WAS EXPECTED THAT THE SEVERED PART WOULD MOVE THROUGH THE GI TRACT WITH NO ADVERSE EFFECT TO THE PATIENT. THE TUBE HAD BEEN PLACED APPROXIMATELY 110 DAYS PRIOR TO ITS REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY-CLARK PEG PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE KNT BALLARD MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other