BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON

    MDR report key: 6115173 · Received November 18, 2016

    Report

    Report Number
    3007934906-2016-00021
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 25, 2016
    Report Date
    November 18, 2016
    Manufacturer
    RESHAPE MEDICAL, INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS INSERTED WITHOUT ISSUE ON (B)(6) 2016. APPROXIMATELY 18 WEEKS AFTER INSERTION, PATIENT COMPLAINED OF ABDOMINAL PAIN AND REQUESTED TO HAVE THE DEVICE REMOVED. THE DEVICE WAS REMOVED ON (B)(6) 2016. UPON REMOVAL, MD NOTED AN ULCER AT THE INCISURA WITH DEPTH OF 1.5 CM. MD CONFIRMED THAT PATIENT'S PAIN RESOLVED ONCE THE BALLOON WAS REMOVED AND PATIENT HAD NO FURTHER SEQUELAE. PATIENT CONTINUED TO TAKE PROTON PUMP INHIBITOR MEDICATION (PROTONIX BID) FOLLOWING REMOVAL AND WAS ALSO PRESCRIBED CARAFATE FOR 8 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762750 RESHAPE INTEGRATED DUAL BALLOON INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 160323-005 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention