BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND

    MDR report key: 2792319 · Received October 12, 2012

    Report

    Report Number
    2792319
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 12, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FIVE YEARS AGO, PATIENT HAD SURGERY FOR LAPAROSCOPIC ISNERTION OF AN ADJUSTABLE GASTRIC BAND. JUST OVER FIVE YEARS LATER, SHE CAME TO SURGERY WITH A DIAGNOSIS OF ERODED LAP BAND FOR WHICH DR PERFORMED A LAPAROSCOPIC REMOVAL OF THE GASTRIC BAND AND REPAIR OF GASTRIC FISTULA. THE LAP-BAND WAS AN ALLERGAN 10.0CM ADJUSTABLE GASTRIC BANDING SYSTEM, REF #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND GASTRIC BANDING SYSTEM, ADJUSTABLE LTI ALLERGAN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R