BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON

    MDR report key: 6437698 · Received March 27, 2017

    Report

    Report Number
    3007934906-2017-00008
    Event Type
    Injury
    Date Received
    March 27, 2017
    Date of Event
    February 23, 2017
    Report Date
    March 27, 2017
    Manufacturer
    RESHAPE MEDICAL, INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6)-YEAR-OLD FEMALE PATIENT HAD THE DEVICE INSERTED ON (B)(6) 2017. ON (B)(6), PATIENT BEGAN TO DEVELOP SYMPTOMS OF BLOATING AND ABDOMINAL PAIN. ON (B)(6), PATIENT PRESENTED AT ER WITH SIGNIFICANT ABDOMINAL PAIN AND DIFFICULTY BREATHING AND WAS ADMITTED. MD PERFORMED EGD ON (B)(6) WITH THE INTENT TO REMOVE THE DEVICE, BUT PRESENCE OF FOOD LED MD TO OPT TO DELAY REMOVAL UNTIL THE FOLLOWING DAY. BALLOONS APPEARED NORMAL AND IN CORRECT POSITION. ON (B)(6), THE DEVICE WAS SUCCESSFULLY REMOVED ENDOSCOPICALLY FROM THE STOMACH. THE PATIENT WAS DISCHARGED AND HAD NO FURTHER SEQUELAE. MD DIAGNOSED THIS ADVERSE EVENT AS GASTRIC OUTLET OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217489 RESHAPE INTEGRATED DUAL BALLOON INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 160727-005 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention