BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 6962341 · Received October 19, 2017

    Report

    Report Number
    3007934906-2017-00031
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    September 8, 2017
    Report Date
    October 19, 2017
    Manufacturer
    RESHAPE MEDICAL INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED TO HOSPITAL ON (B)(6) 2017 DUE TO INTENSE ABDOMINAL PAIN. PAIN WAS MINIMIZED AND PATIENT REQUESTED TO HAVE BALLOONS REMOVED BY IMPLANTING PHYSICIAN. PATIENT WAS DISCHARGED ON (B)(6) 2017 AND TRANSFERRED TO ANOTHER HOSPITAL WHERE IMPLANTING PHYSICIAN REMOVED THE BALLOONS ON SAME DAY. PHYSICIAN CONFIRMED PANCREATITIS BUT DID NOT DISCLOSE TESTING DONE TO CONFIRM PANCREATITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740945 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL INC. 01-0011-001 170803-003 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization