BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 7077449 · Received December 1, 2017

    Report

    Report Number
    3007934906-2017-00037
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    October 25, 2017
    Report Date
    November 20, 2017
    Manufacturer
    RESHAPE MEDICAL INC.
    Product Code
    LTI
    PMA / PMN Number
    P140012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT COMPLAINED OF UPPER ABDOMINAL PAIN AND VOMITING FOR APPROXIMATELY 24 HOURS. PATIENT VISITED HOSPITAL ON (B)(6) 2017 FOR AN OUTPATIENT CT SCAN AND OFFICE EVALUATION AFTER PATIENT CALLED ON SAME DAY. PER MD, ONE WEEK OF WORSENING UPPER ABDOMINAL PAIN, NAUSEA/VOMITING. CT SCAN SHOWED DISTAL BALLOON LARGER THAN PROXIMAL BALLOON WITH AIR FLUID LEVELS. THE BALLOON WAS REMOVED THE NEXT MORNING ON (B)(6) 2017. THE PROXIMAL BALLOON WAS VISIBLY LARGER THAN WHEN PLACED AND VISIBLE AIR FLUID INTERFACE - UNEVENTFUL REMOVAL. PATIENT WAS COMPLIANT WITH TAKING THEIR PPI'S. DATE OF INSERTION: (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854856 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL INC. 01-0011-001 160622-001

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other