BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON

    MDR report key: 6042701 · Received October 19, 2016

    Report

    Report Number
    3007934906-2016-00020
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    April 2, 2016
    Report Date
    October 19, 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

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 FDA REQUESTED THAT THIS COMPLAINT BE FILED AS A MEDICAL DEVICE REPORT.

    Description of Event or Problem · 1

    DEVICE WAS IMPLANTED WITHOUT ISSUE ON (B)(6) 2016. ON (B)(6) 2016 PATIENT WAS ADMITTED TO HOSPITAL AND DIAGNOSED WITH PANCREATITIS ON (B)(6) 2016. PATIENT WAS ADVISED TO HAVE DEVICE REMOVED. PATIENT WAS TREATED AND DISCHARGED ON (B)(6) 2016. BALLOON REMAINED IMPLANTED UNTIL THE SCHEDULED 6-MONTH REMOVAL WAS COMPLETED ON (B)(6) 2016. NO FURTHER SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693337 RESHAPE INTEGRATED DUAL BALLOON INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 151005-002 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization