BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 6419286 · Received March 20, 2017

    Report

    Report Number
    3007934906-2017-00007
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    February 19, 2017
    Report Date
    March 20, 2017
    Manufacturer
    RESHAPE MEDICAL, INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT, WHO WAS SCHEDULED FOR SIX MONTH REMOVAL ON (B)(6) 2017, CONTACTED MD ON (B)(6) 2017 TO REPORT A BOWEL MOVEMENT CONTAINING THE BALLOONS. PATIENT WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200278 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 160624-004 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other