BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERITUS MEDICAL

    MDR report key: 2678554 · Received July 30, 2012

    Report

    Report Number
    2080225-2012-00001
    Event Type
    Malfunction
    Date Received
    July 30, 2012
    Date of Event
    May 6, 2012
    Report Date
    May 29, 2012
    Manufacturer
    KENTEC MEDICAL, INC.
    Product Code
    FPD
    PMA / PMN Number
    K100526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). KENTEC MEDICAL RECEIVED A COPY OF THE REPORT FROM THE FDA VIA POSTAL MAIL ON (B)(4) 2012. THIS WAS THE FIRST NOTIFICATION THAT THERE HAD BEEN A PRODUCT PROBLEM. AS OF THE DATE OF THIS REPORT, (B)(4) 2012, THE SUSPECTED FAILED DEVICE IS NOT AVAILABLE FOR INSPECTION OR ANALYSIS. KENTEC HAS ATTEMPTED TO CONTACT REPORT SUBMITTER ((B)(6)) AT THE PHONE NUMBER PROVIDED, BUT HAS RECEIVED NO RESPONSE. PARTS OF THIS SUBMISSION HAVE BEEN DICTATED AS PER THE ORIGINAL SUBMISSION BY THE USER FACILITY.

    Description of Event or Problem · 1

    CUSTOMER STATED VIA MEDWATCH REPORT DATED (B)(4) 2012, RECEIVED BY KENTEC MEDICAL ON (B)(4) 2012: A NEW POLYURETHANE EIGHT FRENCH AMERITUS NASOGASTRIC (NG) FEEDING TUBE BECAME DISCONNECTED AT THE TUBING HARD PLASTIC, ORANGE PIECE. THE PT¿S FEEDS WERE LOST INTO THE BED. THE MD WAS AWARE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERITUS MEDICAL FEEDING TUBE FPD KENTEC MEDICAL, INC. 105014

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Other