BEUDAMED
    FDA Adverse Event Other Summary report: N

    BALLOON SLG 16 FR X 2.0CM

    MDR report key: 1567336 · Received December 24, 2009

    Report

    Report Number
    1314412-2009-00013
    Event Type
    Other
    Date Received
    December 24, 2009
    Report Date
    December 11, 2009
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2009. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2009 THAT A CUSTOMER HAD AN ISSUE WITH A G-TUBE. THE CUSTOMER REPORTED THE G-TUBE WAS CAUSING THE PT DISCOMFORT. THE CUSTOMER STATED THAT SHE HAD TO PRESS DOWN, AND THEN TURN TO SNAP IT IN TO PLACE; SHE HAS TO APPLY A LOT OF PRESSURE TO THE STOMACH, WHICH CAUSES HER SON DISCOMFORT. SINCE USING THIS DEVICE, THE SITE AROUND IT HAS BECOME IRRITATED AND RESULTED IN AN INFECTION, WHICH WAS TREATED WITH KEFLEX. THE PT WAS BROUGHT TO THE HOSP FOR TREATMENT AND THE G-TUBE NEEDED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLOON SLG 16 FR X 2.0CM G-TUBE KNT COVIDIEN 716200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other