BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON GASTRIC BAND

    MDR report key: 1182739 · Received September 19, 2008

    Report

    Report Number
    1182739
    Event Type
    Injury
    Date Received
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ETHICON ENDO-SURGERY INC.
    Product Code
    LTI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT RETURNED TO OR FOR GASTRIC BAND REMOVAL DUE TO MALFUNCTION. LAPAROSCOPIC INSERTION/REMOVAL OF BAND BUT SURGERY WAS CONVERTED TO OPEN LAPAROTOMY TO REPAIR DAMAGE TO THE STOMACH WHERE BAND HAD ERODED THROUGH THE STOMACH WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON GASTRIC BAND GASTRIC BAND LTI ETHICON ENDO-SURGERY INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention