BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 6961793 · Received October 19, 2017

    Report

    Report Number
    3007934906-2017-00030
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    February 7, 2017
    Report Date
    August 14, 2017
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED VIA MEDWATCH NUMBER MW5071624.

    Description of Event or Problem · 1

    TWO WEEKS FOLLOWING INSERTION, PATIENT EXPERIENCED UPPER GI BLEED THAT WAS REPAIRED WITH PLACEMENT OF ENDOSCOPIC CLIPS. SUBSEQUENTLY, PATIENT EXPERIENCED ADDITIONAL UPPER GI BLEEDS RESULTING IN HOSPITALIZATIONS AND EVENTUAL SURGICAL REPAIR AND LIGATION OF VEINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741970 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL INC. 01-0011-001 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R