BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 119092 · Received September 3, 1997

    Report

    Report Number
    MW1012062
    Event Type
    Other
    Date Received
    September 3, 1997
    Date of Event
    April 26, 1997
    Report Date
    August 29, 1997
    Manufacturer
    MEDICAL INNOVATIONS CORP.
    Product Code
    KNT
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 4/26/97 14F J TUBE INSERTED 1 WEEK AGO. BALLOON INFLATED WITH 12 CC NS. PT RETURNED WITH LEAKING. 11 CC YELLOW TURBID FLUID WITHDRAWN FROM BALLOON, SAME APPEARANCE AS FLUID DRAINING THROUGH TUBE. 4/26 PT #2 PT STATES THAT TUBE INSERTED ON 4/24 FELL OUT. BALLOON WAS DEFLATED. DENIES TAMPERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * JEJUNOSTOMY TUBE KNT MEDICAL INNOVATIONS CORP. * 6121102

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other