BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI ONE® BALLOON BUTTON

    MDR report key: 6263120 · Received January 19, 2017

    Report

    Report Number
    6263120
    Event Type
    Injury
    Date Received
    January 19, 2017
    Date of Event
    January 10, 2017
    Report Date
    January 18, 2017
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT FOR SECOND OPERATING ROOM RELATED TO A GT COMPLICATION ORIGINALLY INSERTED APPROXIMATELY THREE DAYS PREVIOUSLY. PT TO OPERATING ROOM FOR LAP NISSEN/GT (14FR 1.2CM AMT BUTTON) . THREE DAYS LATER IN THE MORNING, FEEDINGS WERE INCREASED. THAT SAME DAY IN THE AFTERNOON, STAY SUTURES REMOVED BY SURGICAL FELLOW. RN FOUND GT (GASTRIC TUBE) ELEVATED AWAY FROM SKIN. UNCLEAR TO RN IF BALLOON WAS FILLED WITH WATER. PT MADE NPO. SURGERY CALLED NOTIFIED. DYE STUDY ORDERED TO ASSESS FOR PROPER PLACEMENT. READING BY RADIOLOGIST STATED THAT GT IN PLACE WITH NO LEAK. CONFIRMED. THAT SAME DAY IN THE EVENING, FEEING WAS RESTARTED. THE FOLLOWING MORNING, GT LEAKING. FORMULA COLORED FLUID ACCUMULATED UNDER DRESSING. NNP NOTIFIED, PT MADE NPO. SURGERY TEAM CALLED AND REMOVED GT AND PLACED 10 FR FOLEY. PT ADMINISTERED ISO DYE BY MD AND X-RAYS OBTAINED. PATIENT SCHEDULED FOR OR. PATIENT WAS TAKEN TO OR THAT DAY: DISLODGED GASTROSTOMY TUBE WITH PERITONITIS,DIAGNOSTIC LAPAROSCOPY, LAPAROTOMY, STAMM GASTROSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47478 MINI ONE® BALLOON BUTTON TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. M1-5-1412-I 161216-054

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Hospitalization| O| R