BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 6608363 · Received June 2, 2017

    Report

    Report Number
    3007934906-2017-00014
    Event Type
    Malfunction
    Date Received
    June 2, 2017
    Date of Event
    May 2, 2017
    Report Date
    June 2, 2017
    Manufacturer
    RESHAPE MEDICAL, INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED FEELING "CRAMPY" AND DEFECATED BALLOON 5 DAYS PRIOR TO SIX-MONTH REMOVAL DATE. PATIENT DID SEE BLUE/GREEN URINE IN THE THREE DAYS PRIOR TO PASSING THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389774 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 161031-002 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other