BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 3360013 · Received September 13, 2013

    Report

    Report Number
    1060680-2013-00008
    Event Type
    Other
    Date Received
    September 13, 2013
    Date of Event
    July 17, 2013
    Report Date
    August 20, 2013
    Manufacturer
    BENLAN INC.
    Product Code
    FPD
    PMA / PMN Number
    K100700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEROYAL: THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THE MFR, BENLAN INC., HAS BEEN NOTIFIED OF THE ISSUE AND THEIR INVESTIGATION INTO THE ROOT CAUSE IS IN PROCESS.

    Description of Event or Problem · 1

    THE NICU NURSES ARE CLAIMING THAT THE FEEDING TUBES HARDEN SIGNIFICANTLY AFTER BEING IN INFANTS FOR A FEW DAYS, CAUSING ESOPHAGEAL TEARS. THE TUBES WILL SLIP OUT WHICH IS A NORMAL OCCURRENCE BUT THEY THINK THAT AT THE TIME OF READJUSTING, TEARS ARE OCCURING DUE TO THE TUBE BEING SO HARD. INFANTS EXPERIENCE TEARS BUT INJURIES WERE NOT LIFE THREATENING NOR DID THEY REQUIRE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462086 DEROYAL FPD BENLAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other