BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIC-KEY

    MDR report key: 19925 · Received January 20, 1995

    Report

    Report Number
    19925
    Event Type
    Other
    Date Received
    January 20, 1995
    Date of Event
    December 25, 1994
    Report Date
    January 16, 1995
    Manufacturer
    MEDICAL INNOVATIONS CORP.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE NEEDED TO BE REPLACED ON TWO OCCASIONS (12/25/94 & 1/7/95) DUE TO MALFUNCTIONING BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC-KEY SKIN LEVEL GASTROSTOMY KIT KNT MEDICAL INNOVATIONS CORP. 4016702

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other