BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON

    MDR report key: 5582765 · Received April 15, 2016

    Report

    Report Number
    3007934906-2016-00006
    Event Type
    Death
    Date Received
    April 15, 2016
    Date of Event
    March 20, 2016
    Report Date
    April 8, 2016
    Manufacturer
    RESHAPE MEDICAL, INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE PATIENT DEATH WAS RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN UNEVENTFUL BALLOON INSERTION ON 2/16/16. PATIENT EXPERIENCED VOMITING AND PAIN AND PRESENTED AT ER ON (B)(6) 2016; DIAGNOSTIC EVALUATION NOTED PRESENCE OF KIDNEY STONE. SUBSEQUENT TREATMENT DURING ER VISIT, IF ANY, WAS NOT REPORTED. PATIENT PRESENTED AT IMPLANTING SURGEON'S ER ON (B)(6) 2016 WITH SEVERE CHEST PAIN. DIAGNOSED AS DISTAL, 1 CM ESOPHAGEAL PERFORATION AND LEAK. STENT PLACED ENDOSCOPICALLY OVER PERFORATION FOLLOWED BY SAME DAY LAPAROSCOPIC REMOVAL OF BALLOON AND REPAIR OF PERFORATION. PHYSICIAN NOTED NORMAL BALLOON APPEARANCE AND POSITION. PATIENT REMAINED HOSPITALIZED WITH SEPSIS AND EXPIRED (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236473 RESHAPE INTEGRATED DUAL BALLOON INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death