BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE

    MDR report key: 2141579 · Received June 9, 2011

    Report

    Report Number
    2141579
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    February 12, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ETHICON
    Product Code
    LTI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    THE PT HAD LAP BAND SURGERY THREE YEARS AGO. THIS PT DEVELOPED CHEST PAIN, SHORTNESS OF BREATH, NAUSEA AND VOMITING SHORTLY AFTER RIDING HER BIKE. SHE WANTED TO COME INTO THE OFFICE TO HAVE THE FLUID REMOVED FROM HER BAND AS SHE THOUGHT IT MIGHT BE TOO TIGHT. SHE WAS ADVISED BY THE DR. TO GO TO THE (B) (6) EMERGENCY ROOM IMMEDIATELY AS IT MAY HAVE A CARDIAC ORIGIN AS WELL AS POSSIBLY BE RELATED TO HER BAND. THE PT HAD A CT SCAN THIS MORNING WHICH SHOWS EVIDENCE OF A LARGE SLIP WITH EMPHYSEMA OF THE GASTRIC WALL AND SOME RETROGASTRIC ASCITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE LAP BAND LTI ETHICON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R