BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 7155047 · Received December 29, 2017

    Report

    Report Number
    3007934906-2017-00038
    Event Type
    Malfunction
    Date Received
    December 29, 2017
    Date of Event
    November 30, 2017
    Report Date
    December 22, 2017
    Manufacturer
    RESHAPE MEDICAL INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED PRACTICE WITH COMPLAINT OF ABDOMINAL PAIN ON (B)(6) 2017 WHICH WAS 142 DAYS POST-PLACEMENT. PATIENT WAS SEEN IN THE OFFICE ON (B)(6) AND AN X-RAY WAS DONE WHICH SHOWED THAT THE BALLOON UNIT HAD DEFLATED AND HAD MIGRATED FROM THE STOMACH. THE PATIENT WAS SENT HOME AND TOLD TO MONITOR STOOL TO DETERMINE IF BALLOON HAD PASSED IN STOOL. THE BALLON UNIT WAS SURGICALLY REMOVED FROM THE LARGE INTESTINE ON (B)(6) 2017 WITHOUT COMPLICATION AND THE PATIENT WAS DISCHARGED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933139 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL INC. 01-0011-001 170420-001 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other