BEUDAMED
    FDA Adverse Event Summary report: N

    SKIN LEVEL GASTROSTOMY KIT

    MDR report key: 21357 · Received April 12, 1995

    Report

    Report Number
    21357
    Date Received
    April 12, 1995
    Date of Event
    March 23, 1995
    Report Date
    April 11, 1995
    Manufacturer
    MEDICAL INNOVATIONS CORP.
    Product Code
    KNT
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    1.7 CM WAS EXTRUDED AND FOUND IN CHILD'S DIAPER. BALLOON WAS RUPTURED. DEVICE ORIGINALLY INSERTED ON 12/16/94. A MALFUNCTIONING BALLOON WAS ALSO REPORTED ON 1/16/95, REPORT #36-3306-1995-001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKIN LEVEL GASTROSTOMY KIT SKIN LEVEL GASTROSTOMY KIT KNT MEDICAL INNOVATIONS CORP. 4066702

    Patients

    Seq Age Sex Outcome Treatment
    1 *