BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEG TUBE

    MDR report key: 21767 · Received May 11, 1995

    Report

    Report Number
    MW1005905
    Event Type
    Malfunction
    Date Received
    May 11, 1995
    Date of Event
    April 18, 1995
    Report Date
    April 26, 1995
    Manufacturer
    MEDICAL INNOVATIONS CORP.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    G-TUBE INSERTED IN GI LAB 6/94. PT RETURNED TO GI LAB WITH RETENTION "BUMPER" SEPARATED FROM G-TUBE AND IN PT'S BOWEL. KUB DONE AND G-TUBE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEG TUBE Implant KNT MEDICAL INNOVATIONS CORP. 0160-20

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other