BEUDAMED
    FDA Adverse Event Death Summary report: N

    PEG-12 BALLOON REPLACEMENT TUBE

    MDR report key: 183280 · Received August 20, 1998

    Report

    Report Number
    1037905-1998-00037
    Event Type
    Death
    Date Received
    August 20, 1998
    Date of Event
    June 27, 1998
    Report Date
    July 27, 1998
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    KNT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY PLACED A BALLOON REPLACMENT TUBE. TEN DAYS FOLLOWING THE PROCEDURE, IT WAS NOTICED THAT THE CATHETER DISLOCATED FROM THE ABDOMINAL WALL AND THE BALLOON WAS DEFLATED. A LAPARATOMY WAS PERFORMED AND REVEALED 2 LITERS OF NUTRITIONAL FLUID IN FREE ABDOMINAL SPACE AND AN OPENING IN THE ANTERIOR SIDE OF THE STOMACH. THE PT WAS DIAGNOSED WITH PERITONITIS AND TAKEN TO SURGERY TO REPAIR THE STOMACH PERFORATION AND GASTROSTOMY. THE PT DIED A FEW HOURS AFTER SURGERY AS A RESULT OF PERITONITIS. CASE HISTORY EVALUATION STATES THAT THE BALLOON MAY HAVE DISLODGED ON THE SEVENTH DAY; HOWEVER, WAS NOT DISCOVERED UNTIL THE TENTH DAY. NO FURTHER INFO IS AVAILABLE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEG-12 BALLOON REPLACEMENT TUBE Implant GASTROSTOMY DEVICE KNT WILSON-COOK MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death