BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDICAL INNOVATIONS CORP. GASTROSTOMY TUBE

    MDR report key: 145736 · Received January 21, 1998

    Report

    Report Number
    1719891-1998-00001
    Event Type
    Death
    Date Received
    January 21, 1998
    Date of Event
    November 9, 1997
    Report Date
    January 21, 1998
    Manufacturer
    BALLARD MEDICAL PRODUCTS
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 78 Y/O MALE PT WITH A HISTORY OF DIABETES SUFFERED A STROKE ON 11/17/97. IT WAS REPORTED BY THE FACILITY THAT THE STROKE WAS CHARACTERIZED BY A SUDDEN ONSET OF DYSPHAGIA. ON 11/18/97, THE MFR'S GASTROSTOMY TUBE WAS INSERTED UNDER GENERAL ANESTHESIA USING AN OPEN "STAMM" PROCEDURE. THERE IS NO OTHER INFO AVAILABLE CONCERNING OTHER SURGICAL PROCEDURES DONE AT THE SAME TIME. THE TUBE WAS ALSO SUTURED IN PLACE ABOVE THE SKIN LINE. IT IS REPORTED THAT THE GASTROSTOMY TUBE BALLOON RUPTURED CAUSING PERITONITIS. THE PT EXPIRED ON 11/19/97. IT IS DIFFICULT TO ACCESS THE CAUSE OF THE INCIDENT, BUT IT MAY BE DUE IN PART TO THE PT'S COMPROMISED CONDITION. WITH A STAMM PROCEDURE IT IS UNKNOWN HOW A RUPTURED BALLOON WITH THE TUBE SUTURED IN PLACE COULD CAUSE PERITONITIS. THE MFR HAS RECEIVED NO OTHER REPORTS OF GASTROSTOMY TUBE BALLOONS BURSTING AND THEREBY CAUSING PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL INNOVATIONS CORP. GASTROSTOMY TUBE Implant ENTERAL FEEDING TUBE KNT BALLARD MEDICAL PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death