BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON

    MDR report key: 6156493 · Received December 8, 2016

    Report

    Report Number
    3007934906-2016-00022
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    October 17, 2016
    Report Date
    December 7, 2016
    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 INSERTION PROCEDURE ON (B)(6) 2016. LATER THAT DAY, THE PATIENT HAD SEVERAL EPISODES OF HEMATEMESIS AND UNDERWENT AN EGD THAT SAME DAY. THE BALLOONS WERE NOTED TO BE IN GOOD POSITION IN THE STOMACH. TWO LINEAR ESOPHAGEAL MUCOSAL TEARS EACH APPROXIMATELY 2 CM IN LENGTH WERE NOTED ON THE POSTERIOR ESOPHAGUS. NO BRISK BLEEDING BUT SOME OOZING WAS OBSERVED. BOTH TEARS WERE LIGHTLY CAUTERIZED AND FIBRIN GLUE WAS APPLIED. AN UPRIGHT CHEST X-RAY WAS TAKEN IN THE RECOVERY UNIT, WHICH CONFIRMED THE ABSENCE OF ANY ESOPHAGEAL PERFORATIONS. THE PATIENT WAS SENT HOME WITH NO FURTHER SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804926 RESHAPE INTEGRATED DUAL BALLOON INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. RSM101 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| O