BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    MDR report key: 7047210 · Received November 20, 2017

    Report

    Report Number
    3007934906-2017-00036
    Event Type
    Injury
    Date Received
    November 20, 2017
    Date of Event
    October 21, 2017
    Report Date
    November 16, 2017
    Manufacturer
    RESHAPE MEDICAL INC.
    Product Code
    LTI
    UDI-DI
    B001RSM1011
    PMA / PMN Number
    P140012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    POST-OP ESOPHAGEAL INJURY DURING BALLOON RETRIEVAL PROCEDURE ON (B)(6) 2017. POST REMOVAL PATIENT COMPLAINED OF MILD CRAMPING ON RIGHT SCAPULA. PHYSICIAN OFFERED TO DO X-RAY OR CT SCAN, BUT PATIENT REFUSED. PATIENT VISITED HOSPITAL ON (B)(6) 2017 AND WAS ADMITTED FOR CT SCAN AND OBSERVATION DUE TO POSSIBLE ESOPHAGEAL LACERATION - NO SURGICAL INTERVENTION WAS REQUIRED. PATIENT WAS SENT HOME ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824006 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL INC. RSM101 161031-001 B001RSM1011

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization