BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 6274080 · Received January 24, 2017

    Report

    Report Number
    3007934906-2017-00004
    Event Type
    Injury
    Date Received
    January 24, 2017
    Date of Event
    January 12, 2017
    Report Date
    January 24, 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 HAD BALLOON INSERTED ON (B)(6) 2016. ON (B)(6) 2017, PATIENT REPORTED HAVING HAD CRAMPS, NAUSEA AND NO BOWEL MOVEMENT FOR 5 DAYS. PHYSICIAN INSTRUCTED PATIENT TO TAKE MILK OF MAGNESIA, ZOFRAN AND LEVSIN. ON (B)(6) 2017, PHYSICIAN REPORTED THAT PATIENT WAS STILL BLOATED AND FEELING NAUSEOUS WHILE EXPERIENCING DIARRHEA. PHYSICIAN SENT THE PATIENT TO THE ER FOR IV FLUIDS. PATIENT HAD BLOODWORK AND ULTRASOUND, WHICH WAS NEGATIVE FOR GALLSTONES. HOWEVER, PATIENT WAS DIAGNOSED WITH PANCREATITIS. CT SCAN CONFIRMED BALLOONS WERE INFLATED. ON (B)(6) 2017, PHYSICIAN REFERRED PATIENT TO LOCAL PHYSICIAN TO HAVE BALLOONS REMOVED. BALLOONS WERE REMOVED ON (B)(6) 2017. THE PATIENT WAS DISCHARGED HOME AND REPORTED TO BE STABLE WITH NO FURTHER SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57038 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 161214-001 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other