BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON

    MDR report key: 5536959 · Received March 30, 2016

    Report

    Report Number
    3007934906-2016-00003
    Event Type
    Injury
    Date Received
    March 30, 2016
    Date of Event
    February 24, 2016
    Report Date
    April 6, 2016
    Manufacturer
    RESHAPE MEDICAL, INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE LABELING ADDRESSES THE REPORTED EVENT BY INCLUDING ULCERATION IN THE LIST OF POTENTIAL RISKS. THE DEVICE LABELING ALSO WARNS THAT "FAILURE OF PATIENTS TO TAKE PRESCRIBED DAILY PROTON PUMP INHIBITOR MEDICATION INCREASES THE RISK OF GASTRIC ULCERATION OR PERFORATION." THE DEVICE IS CONTRAINDICATED FOR "PATIENTS WHO ARE UNABLE OR UNWILLING TO TAKE PRESCRIBED PROTON PUMP INHIBITOR MEDICATION FOR THE DURATION OF THE DEVICE IMPLANT."

    Description of Event or Problem · 1

    PATIENT WITH BALLOON PLACED (B)(6) 2015 PRESENTED AT ER WITH UGI BLEED ON (B)(6) 2016. EGD ON (B)(6) 2016 CONFIRMED ULCER AT INCISURA, TREATED WITH EPINEPHRINE AND ENDOCLIPS. PATIENT WAS DISCHARGED ON (B)(6) 2016 AND HAD BALLOON REMOVED ON (B)(6) 2016 BY IMPLANTING PHYSICIAN. PATIENT REPORTED THAT SHE HAD NOT BEEN COMPLIANT WITH INSTRUCTIONS AND HAD STOPPED TAKING DAILY PROTON PUMP INHIBITOR MEDICATION 3 MONTHS AFTER BALLOON PLACEMENT, RATHER THAN COMPLETE THE FULL 6-MONTH COURSE OF MEDICATION AS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190407 RESHAPE INTEGRATED DUAL BALLOON INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 150817-003 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R