BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON

    MDR report key: 6156921 · Received December 8, 2016

    Report

    Report Number
    3007934906-2016-00023
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    November 10, 2016
    Report Date
    December 8, 2016
    Manufacturer
    RESHAPE MEDICAL, INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS INSERTED WITHOUT ISSUE ON (B)(6) 2016. APPROXIMATELY 10 WEEKS AFTER INSERTION, PATIENT BECAME UNABLE TO TOLERATE SOLID FOODS. A UGI SERIES WAS PERFORMED ON (B)(6) 2016 AND CONFIRMED A GASTRIC OUTLET OBSTRUCTION. THE DEVICE WAS REMOVED WITHOUT ISSUE ON (B)(6) 2016 AND NO FURTHER SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806806 RESHAPE INTEGRATED DUAL BALLOON INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 160525-002 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention