BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 6360804 · Received February 27, 2017

    Report

    Report Number
    3007934906-2017-00006
    Event Type
    Malfunction
    Date Received
    February 27, 2017
    Date of Event
    January 31, 2017
    Report Date
    February 27, 2017
    Manufacturer
    RESHAPE MEDICAL, INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING SCHEDULED SIX MONTH ENDOSCOPIC REMOVAL PROCEDURE, MD NOTED BALLOONS WERE NOT PRESENT IN STOMACH. MD ORDERED AN ABDOMINAL CT SCAN, WHICH CONFIRMED NO DEVICE PRESENT IN THE GI TRACT. MD CONCLUDED UNIT SPONTANEOUSLY PASSED DURING A BOWEL MOVEMENT WITHOUT ISSUE. PATIENT WAS ASYMPTOMATIC AND DID NOT NOTICE THE DEVICE IN ANY BOWEL MOVEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144594 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other