BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC REPLACEMENT PEG TUBE

    MDR report key: 504777 · Received January 6, 2004

    Report

    Report Number
    504777
    Event Type
    Malfunction
    Date Received
    January 6, 2004
    Date of Event
    May 1, 2003
    Report Date
    September 1, 2003
    Manufacturer
    MIC
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PEG [PERCUTANEOUS ENDOSCOPIC GASTROTOMY] TUBE RUPTURED AND HAD TO BE REPLACED. THE MIC PEG THAT WAS INSERTED IN 2002 RUPTURED AND WAS REPLACED. AS REPORTER UNDERSTANDS IT, THIS IS NOT UNCOMMON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC REPLACEMENT PEG TUBE PEG TUBE KNT MIC * 170790

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR TUBE FEEDINGS.