BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 6997984 · Received November 2, 2017

    Report

    Report Number
    3007934906-2017-00033
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    August 27, 2017
    Report Date
    November 1, 2017
    Manufacturer
    RESHAPE MEDICAL INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT RESHAPE BALLOON INSERTION PROCEDURE ON (B)(6) 2017. TEN DAYS LATER THE PATIENT WENT TO THE HOSPITAL FOR HYDRATION TREATMENT AND ABDOMINAL PAIN. THE PATIENT WAS ADMITTED TO HOSPITAL AND A CAT SCAN WAS PERFORMED AND RESULTS WERE NORMAL. THE BALLOONS WERE REMOVED ON (B)(6) 2017 DUE TO INTOLERANCE AND THE PATIENT WAS DISCHARGED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775570 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL INC. 01-0011-001 160218-003 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization