BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDICAL INNOVATIONS CORP. PERCUTANEOUS ENDOSCOPIC GASTROSTOM

    MDR report key: 138875 · Received December 16, 1997

    Report

    Report Number
    1719891-1997-00003
    Event Type
    Death
    Date Received
    December 16, 1997
    Date of Event
    October 21, 1997
    Report Date
    December 15, 1997
    Manufacturer
    BALLARD MEDICAL PRODUCTS
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 14 YR OLD FEMALE PT WITH A PRIMARY DIAGNOSIS OF CEREBRAL PALSY HAD A GASTRIC FEEDING TUBE PLACED ON 10/16/97. SHE HAD A NASOGASTRIC TUBE BEFORE THE PEG INSERTION. THE PT DID WELL POSTOPERATIVELY AND WAS DISCHARGED TO THE CARE OF HER FOSTER PARENTS. IT IS NOT KNOWN WHETHER DISCHARGE TEACHING WAS GIVEN TO THE CARE GIVERS OR IF THE CARE GIVERS HAD PRIOR TUBE FEEDING EXPERIENCE. ON 10/20/97, THE PT WAS READMITTED THROUGH THE EMERGENCY ROOM WITH PERITONITIS CAUSED BY FORMULA EXTRAVASATION BETWEEN THE STOMACH AND THE ABDOMINAL WALL. IT WAS REPORTED BY THE FOSTER PARENTS THAT THE INTERNAL RETENTION DOME HAD COLLAPSED AND THE TUBE HAD "WORKED ITS WAY OUT". THE MFR HAS HAD NO REPORTS OF THIS DEVICE BEING UNINTENTIONALLY REMOVED UNLESS AN EXCESSIVE TRACTION FORCE WAS INTENTIONALLY OR UNINTENTIONALLY APPLIED TO THE DEVICE PULLING IT OUT OF THE ABDOMEN. THE DEVICE IS UNAVAILABLE FOR INSPECTION. THE PT EXPIRED ON 10/21/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL INNOVATIONS CORP. PERCUTANEOUS ENDOSCOPIC GASTROSTOM Implant ENTERAL FEEDING TUBE KNT BALLARD MEDICAL PRODUCTS NA 0424P7

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Death