BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GASTROJEJUNOSTOMY TUBE

    MDR report key: 3833650 · Received May 19, 2014

    Report

    Report Number
    MW5036207
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    June 26, 2013
    Report Date
    May 19, 2014
    Manufacturer
    UNK
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    G-TUBE PLACED (B)(6) 2013. PT RETURNED TO SURGERY (B)(6) 2013. BALLOON WAS FOUND DEFLATED AND WAS REINSUFFLATED ON THE G-TUBE PORT. AT THE END OF THE SURGICAL CASE (ABOUT 2 HOURS LATER) THE BALLOON HAD DECREASED TO ABOUT HALF THE SIZE AFTER INSUFFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295396 GASTROJEJUNOSTOMY TUBE KNT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention