BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON

    MDR report key: 6440947 · Received March 28, 2017

    Report

    Report Number
    3007934906-2017-00009
    Event Type
    Injury
    Date Received
    March 28, 2017
    Date of Event
    March 10, 2017
    Report Date
    March 27, 2017
    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

    DEVICE WAS INSERTED WITHOUT ISSUE ON (B)(6) 2016. MORE THAN FOUR MONTHS AFTER INSERTION, PATIENT COMPLAINED OF ABDOMINAL PAIN, NAUSEA, AND VOMITING. MD DIAGNOSED ISSUE AS GASTRIC OUTLET OBSTRUCTION. MD CONFIRMED NO EVIDENCE OF ACUTE PANCREATITIS. DEVICE WAS REMOVED ON (B)(6) 2017 WITHOUT ISSUE. NO FURTHER SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222038 RESHAPE INTEGRATED DUAL BALLOON INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 160727-002 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention