BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICAL INNOV, CORP. GASTROSTOMY TUBE

    MDR report key: 185910 · Received August 31, 1998

    Report

    Report Number
    1719891-1998-00011
    Event Type
    Injury
    Date Received
    August 31, 1998
    Date of Event
    July 9, 1998
    Report Date
    August 14, 1998
    Manufacturer
    BALLARD MEDICAL PRODUCTS
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ON 8/14/1998 A MEDWATCH FORM CONCERNING THIS INCIDENT WAS SUBMITTED BY THE MFR. SINCE THAT REPORT CO HAS RECEIVED THE FOLLOWING INFO: A GASTRIC FEEDING TUBE WAS PLACED ON AN 87 YEAR OLD FEMALE PT IN INTERVENTIONAL RADIOLOGY ON 7/8/1998. THE PT'S MEDICAL HISTORY AND MEDICAL CONDITION PRIOR TO TUBE PLACEMENT ARE STILL UNK. THE BALLOON WAS FILLED WITH RADIOPAQUE DYE TO ASSURE PLACEMENT. IT IS REPORTED THAT THE PT EXPERIENCED ABDOMINAL PAIN LATER THAT DAY. ON THE FOLLOWING DAY THE PAIN HAD DECREASED, BUT WAS STILL PRESENT. MAGNESIUM CITRATE WAS ADMINISTERED THROUGH THE GASTROSTOMY TUBE, 24 HOURS AFTER PLACEMENT. PLACEMENT OF THE TUBE IN THE STOMACH WAS NOT VERIFIED PRIOR TO THE ADMINISTRATION OF THIS MEDICATION. IT HAS BEEN REPORTED THAT THE BALLOON DEFLATED AND THE TUBE MIGRATED OUT OF THE STOMACH. IT IS NOT KNOWN HOW THE TUBE WAS SECURED INTO PLACE OR IF THE STOMACH WAS SECURED TO THE ABDOMINAL WALL. THE PT DEVELOPED MAGNESIUM TOXICITY WITH THE HOSP PRESUMED WAS FROM PERITONEAL ABSORPTION AND LATER SUFFERED CARDIAC ARREST AND HYPOXIC BRAIN INJURY. THE USE OF MAGNESIUM CITRATE IS CONTRAINDICATED WHEN ABDOMINAL PAIN IS PRESENT AND CAN CAUSE ABDOMINAL CONVULSIONS SUFFICIENT TO DISPLACE THE FEEDING TUBE. IT IS UNCLEAR TO THE MFR IF THIS OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L| O
    2 *