BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON

    MDR report key: 5445605 · Received February 18, 2016

    Report

    Report Number
    3007934906-2016-00001
    Event Type
    Injury
    Date Received
    February 18, 2016
    Date of Event
    December 30, 2015
    Report Date
    January 25, 2016
    Manufacturer
    RESHAPE MEDICAL, INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SENT TO ER AND ADMITTED TO HOSPITAL WITH NAUSEA, VOMITING, AND DEHYDRATION ON (B)(6) 2015, ONE DAY AFTER HAVING THE BALLOON PLACED ON (B)(6) 2015. THE PATIENT WAS TREATED WITH IV FLUIDS AND IV ANTI-EMETICS ON (B)(6)2015. THE PATIENT'S SYMPTOMS WERE MUCH IMPROVED THE FOLLOWING DAY AND THE PATIENT WAS DISCHARGED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101785 RESHAPE INTEGRATED DUAL BALLOON INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 151013-005 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization