BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 6274054 · Received January 24, 2017

    Report

    Report Number
    3007934906-2017-00001
    Event Type
    Injury
    Date Received
    January 24, 2017
    Date of Event
    December 23, 2016
    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 ON (B)(6) 2016. ON (B)(6) 2016 PATIENT HAD A RHINOPLASTY. POST RHINOPLASTY, PATIENT WAS PRESCRIBED AN ORAL STEROID FOR 10-14 DAYS. PATIENT VISITED ER ON (B)(6) 2016 WITH COMPLAINTS OF STOMACH PAIN. CT SCAN SHOWED A GASTRIC PERFORATION 2-3 MM IN DIAMETER. BALLOON WAS REMOVED ENDOSCOPICALLY ON (B)(6) 2016 AND THE PERFORATION WAS REPAIRED LAPAROSCOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58041 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 160421-009 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention