BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC (MEDICAL INNOVATIONS CORP)

    MDR report key: 245077 · Received October 18, 1999

    Report

    Report Number
    MW1017338
    Event Type
    Injury
    Date Received
    October 18, 1999
    Date of Event
    October 15, 1999
    Report Date
    October 18, 1999
    Manufacturer
    BALLARD MEDICAL PRODUCTS
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TRANSGASTRIC JEJUNAL TUBE PLACED ON 10/14/99 UNDER FLUOROSCOPY(TO REPLACE PREVIOUS DEFECTIVE TUBE). ON 10/15, THE BALLOON WAS VISIBLE AND NOTED TO BE LEAKING. TUBE WAS SECURED IN PLACE AND MD NOTIFIED ON 10/16 MORNING. TUBE REMOVED. PLANS ARE TO NOT REPLACE DUE TO OBVIOUS FAULTY PRODUCT. SECOND TUBE WITH BALLOON RUPTURE IN ONE WEEK. BALLARD MEDICAL NOTIFIED 10/18/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC (MEDICAL INNOVATIONS CORP) Implant TRANSGASTRIC JEJUNAL FEEDING KIT KNT BALLARD MEDICAL PRODUCTS * 75934

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention