BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORFLO MAX PEG KIT

    MDR report key: 4858597 · Received June 15, 2015

    Report

    Report Number
    4858597
    Event Type
    Injury
    Date Received
    June 15, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 12, 2015
    Manufacturer
    CORPAK MEDSYSTEMS INC
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT #1 HAD A PEG (PERCUTANEOUS ENDOCSCOPIC GASTROSTROMY) TUBE PLACEMENT ON WITH NO INCIDENT. MONTHS LATER, PATIENT RETURNED FOR REMOVAL OF PEG AND PLACEMENT OF CORFLO FEEDING TUBE WITHOUT INCIDENT. XRAY TAKEN - CORFLO NOTED TO BE IN THE PERTONEAL CAVITY WHICH INDICATED PEG SEPARATION. PATIENT ADMITTED AND OPERATED SAME EVENING. PATIENT DISCHARGED HOME NEXT DAY WITHOUT INCIDENT.PATIENT #2 - SAME IDENTICAL EVENTS EXCEPT DATES- PLACED PEG EARLIER THIS YEAR- SURGERY AND CORFLO EXCHANGE SEVERAL MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389947 CORFLO MAX PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CORPAK MEDSYSTEMS INC * 68959- 1ST PAT- 2ND PAT-69116

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Other| R
    2 *