BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON

    MDR report key: 5485188 · Received March 7, 2016

    Report

    Report Number
    3007934906-2016-00002
    Event Type
    Malfunction
    Date Received
    March 7, 2016
    Date of Event
    February 12, 2016
    Report Date
    March 7, 2016
    Manufacturer
    RESHAPE MEDICAL, INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING ADDRESSES THE REPORTED EVENT AS FOLLOWS: "ALTHOUGH THE RESHAPE DUAL BALLOON DESIGN PROVIDES AN ANTI-MIGRATION FEATURE, THERE IS THE POTENTIAL RISK OF DEVICE MIGRATION AND INTESTINAL OBSTRUCTION...IF INTESTINAL MIGRATION OCCURS, THE DEVICE MAY PASS THROUGH THE INTESTINE AND BE PASSED WITH STOOL."

    Description of Event or Problem · 1

    DEVICE PLACED ON (B)(6) 2015; PATIENT PRESENTED AT ER ON (B)(6) 2016 AND INITIAL IMAGING (CT) SHOWED THE DEFLATED DEVICE IN THE TERMINAL ILEUM. DIAGNOSTIC LAPAROSCOPY PERFORMED LATER ON(B)(6) SHOWED DEVICE MOVED INTO COLON. PATIENT CHECKED SELF OUT OF HOSPITAL ON (B)(6) AND REPORTED DEVICE EXCRETED IN STOOL ON (B)(6) 2016. PATIENT REPORTED THAT SYMPTOMS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140133 RESHAPE INTEGRATED DUAL BALLOON INTRAGASTRIC BALLOON, PRODUCT CODE: LTI LTI RESHAPE MEDICAL, INC. 01-0011-001 150817-003 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization