BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 6583328 · Received May 22, 2017

    Report

    Report Number
    3007934906-2017-00015
    Event Type
    Death
    Date Received
    May 22, 2017
    Date of Event
    May 10, 2017
    Report Date
    May 22, 2017
    Manufacturer
    RESHAPE MEDICAL, INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT, INCLUDING AUTOPSY RESULTS. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Description of Event or Problem · 1

    PER MD, PATIENT HAD BALLOON INSERTION ON (B)(6) 2017 WITHOUT INCIDENT. PATIENT LEFT THE OFFICE POST-PROCEDURE ALERT, ORIENTED, AND STABLE. PER MD, MD RECEIVED A PHONE CALL FROM PATIENT'S SISTER THE MORNING OF (B)(6) 2017 AT 8:30AM, INDICATING THE PATIENT HAD BEEN VOMITING OFF AND ON THROUGHOUT THE NIGHT AND SEEMED LETHARGIC. AS THE MD WAS SPEAKING WITH THE SISTER, SISTER STATED THE PATIENT VOMITED AGAIN AND WAS "TURNING BLUE". MD INSTRUCTED SISTER TO CALL 911 IMMEDIATELY. SISTER CALLED BACK LATER ON THE MORNING OF (B)(6) 2017 (AROUND 9:30AM) INDICATING THE PATIENT HAD EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363386 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 161107-002 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death