BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 6586491 · Received May 23, 2017

    Report

    Report Number
    3007934906-2017-00017
    Event Type
    Malfunction
    Date Received
    May 23, 2017
    Date of Event
    May 3, 2017
    Report Date
    May 23, 2017
    Manufacturer
    RESHAPE MEDICAL, INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT ENDOSCOPY FOR ROUTINE 6-MONTH REMOVAL OF THE DEVICE ON (B)(6) 2017. UPON INSERTION OF THE GASTROSCOPE INTO THE STOMACH, MD NOTED THAT THE BALLOONS WERE NOT PRESENT IN THE PATIENT'S STOMACH OR DUODENUM. MD PERFORMED SMALL BOWEL ENTEROSCOPY TO THE PROXIMAL ILEUM AND CONFIRMED ABSENCE OF THE BALLOONS. A SUBSEQUENT KUB (X-RAY) DID NOT SHOW THE BALLOONS IN THE PATIENT'S SMALL BOWEL OR COLON. A CT OF THE ABDOMEN AND PELVIS WAS PERFORMED ON (B)(6) 2017 WHICH CONFIRMED NO RETAINED FOREIGN BODY AND NO ACUTE INTRA-ABDOMINAL OR PELVIC ABNORMALITY IDENTIFIED. MD CONCLUDED THAT THE PATIENT DID NOT NOTICE THAT THE DEVICE HAD SPONTANEOUSLY PASSED IN A BOWEL MOVEMENT. PATIENT DID MENTION FEELING STOMACH ACHES AND DIARRHEA A FEW WEEKS PRIOR TO (B)(6) 2017. PATIENT DID NOT NOTE ANY BLUE-GREEN URINE AND WAS COMPLIANT WITH TAKING PPI MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366242 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 160428-001 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other