BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIFLO INVERTA-PEG GASTROSTOMY KIT

    MDR report key: 670807 · Received February 1, 2006

    Report

    Report Number
    1528738-2006-00003
    Event Type
    Injury
    Date Received
    February 1, 2006
    Date of Event
    January 12, 2006
    Report Date
    January 17, 2006
    Manufacturer
    ROSS PRODUCTS DIVISION
    Product Code
    KNT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE INSERTION OF AN INVERTAPEG OTG TUBE, THE PLASTIC PART DISCONNECTED AS IT WAS BEING PULLED THROUGH THE ABDOMINAL WALL, AND THE REMAINDER OF THE SILICONE TUBE STAYED INSIDE THE PATIENT'S STOMACH AND HAD TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED USING A NEW PERCUTANEIOUS ENDOSCOPIC KIT. THERE WERE NO UNTOWARD EFFECTS TO THE PATIENT. THERE WAS NO REPORT OF SERIOUS INJURY OR ILLNESS ASSOCIATED WITH THE EVENT. HOWEVER, THE PATIENT REQUIRED A MEDICAL INTERVENTION TO PRECLUDE A SERIOUS INJURY OR ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFLO INVERTA-PEG GASTROSTOMY KIT 78 KNT TUBES, GASTROINTESTINAL AND ACCESSORIES KNT ROSS PRODUCTS DIVISION 52354 33789GZ

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention