BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 7022771 · Received November 10, 2017

    Report

    Report Number
    3007934906-2017-00035
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    October 9, 2017
    Report Date
    November 2, 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

    PATIENT REPORTED BLOOD IN STOOL. BALLOON WAS REMOVED ON (B)(6) 2017 AND AN ULCER WAS DISCOVERED IN STOMACH AND WAS BIOPSIED. PATIENT HAD BEEN TAKING ADVIL DUE TO BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800257 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL INC. 01-0011-001 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention