BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC

    MDR report key: 85791 · Received June 28, 1996

    Report

    Report Number
    85791
    Event Type
    Injury
    Date Received
    June 28, 1996
    Date of Event
    February 14, 1996
    Report Date
    February 23, 1996
    Manufacturer
    MEDICAL INNOVATIONS CORP
    Product Code
    KNT
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED ON 2/14/96 FOR REPLACEMENT OF PEG THAT HAD BEEN PLACED ON 1/9/96 (PROBLEM WITH INTERMITTENT OCCLUSION). DEVICE INVOLVED WAS PLACED WITH INITIAL COMPLAINT OF MILD PAIN, COULD NOT AUSCULTATE; BALLOON DEFLARED AND REPLACED; TUBE FLUSHED WITH 30CC FLUID AUSCULTATED X2; TOLERATED WELL; D/C HOME- LATER THE SAME DAY, RETURNED FOR KUB AFTER C/O OF ABDOMINAL AND CHESTPAIN APPROX. ONE HOUR INTO FEEDING; X-RAY WITH CONTRAST INDICATED MALPOSITION OF TUBE; TUBE REMOVED; EGD WITH UNSUCCESSFUL GUIDE WIRE PLACEMENT- NGT PLACED; BP AND DECREASED SAO2; FLUIDS STARTED, TRANSFERRED TO ICU; EGD WITH PEG REINSERTION, STABILIZED; D/C HOME 2/17/96 ON TUBE FEEDINGS- BACK TO BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC GASTROSTOMY TUBE SILICONE RUBBER #22 FRENCH KNT MEDICAL INNOVATIONS CORP * 4120701

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| R