BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 6274079 · Received January 24, 2017

    Report

    Report Number
    3007934906-2017-00003
    Event Type
    Injury
    Date Received
    January 24, 2017
    Date of Event
    January 1, 2017
    Report Date
    January 24, 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

    PATIENT HAD BALLOON INSERTED WITHOUT ISSUE ON (B)(6) 2016. PATIENT EXPERIENCED UNREMITTING NAUSEA WITH EMESIS AND TRANSIENT RENAL INSUFFICIENCY BEGINNING (B)(6) 2016. ON (B)(6) 2017 PATIENT WAS ADMITTED TO HOSPITAL FOR IV FLUIDS AND THIAMINE. ISSUES RESOLVED WITHOUT FURTHER SEQUELAE AND PATIENT WAS DISCHARGED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57223 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization