BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP BAND AP

    MDR report key: 4192281 · Received October 16, 2014

    Report

    Report Number
    4192281
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Date of Event
    June 5, 2014
    Report Date
    October 16, 2014
    Manufacturer
    ALLERGAN INC
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A LAP VERTICAL ROUX EN Y GASTRIC BYPASS APPROXIMATELY 6 YEARS AGO THEN HAD A LAP REVISION OF PRIOR GASTRIC BYPASS PROCEDURE AND GASTROJEJUNOSTOMY WITH GASTRIC BAND APPROXIMATELY 1 YEAR AGO. PRESENTED TO MD OFFICE 4 MONTHS AGO WITH COMPLAINTS OF RUQ PAIN AND OCCSSSIONAL EPIGASTRIC PAIN. UPPER GI DONE AT THAT TIME SHOWED SMALL HIATAL HERNIA. REMOVAL OF BAND DONE APPROXIMATELY 3 MONTHS LATER SHOWED LEAKING ADJUSTABLE GASTRIC BAND SO BAND EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659770 LAP BAND AP IMPLANT, GASTRIC, MORBID OBESITY LTI ALLERGAN INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR