BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 6295148 · Received February 1, 2017

    Report

    Report Number
    3007934906-2017-00005
    Event Type
    Injury
    Date Received
    February 1, 2017
    Date of Event
    January 12, 2017
    Report Date
    February 1, 2017
    Manufacturer
    RESHAPE MEDICAL, INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS INSERTED WITHOUT ISSUE ON (B)(6) 2016. PATIENT CONTACTED IMPLANTING PHYSICIAN ON 1/10/2017 REPORTING NAUSEA AND VOMITING. ON (B)(6) 2017, PATIENT WAS ADMITTED TO THE HOSPITAL WITH RECURRENT NAUSEA, VOMITING, AND DEHYDRATION IN THE CONTEXT OF REFRACTORY GERD. IMPLANTING PHYSICIAN ALSO DIAGNOSED PATIENT AS HAVING HYPOKALEMIA. PATIENT REQUESTED THAT THE DEVICE BE REMOVED AND REMOVAL WAS COMPLETED ON (B)(6) 2017. ON THE SAME DAY, POST-REMOVAL, PATIENT SPIKED A FEVER AND WAS DIAGNOSED WITH ASPIRATION PNEUMONITIS. PATIENT WAS TREATED OVERNIGHT WITH IV ANTIBIOTICS AND DISCHARGED ON (B)(6) 2017 WITH ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77554 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-00011-001 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization