BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 6997986 · Received November 2, 2017

    Report

    Report Number
    3007934906-2017-00034
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    September 6, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD BALLOON IMPLANTED ON (B)(6) 2017 AND REPORTED VOMITING POST PROCEDURE. PATIENT HAD A BLEEDING ULCER AND NEEDED A TRANSFUSION. MD AT HOSPITAL REMOVED THE BALLOON ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775566 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL INC. 01-0011-001 170712-002 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O