BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 3772183 · Received January 2, 2014

    Report

    Report Number
    2024601-2013-01068
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Date of Event
    July 31, 2013
    Report Date
    December 12, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER OR MODEL NUMBER. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS EITHER A TAPER II OR RAPIDPORT EX STRAIN RELIEF. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. NO ADD'L INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE MODEL NUMBER, SERIAL NUMBER, THE EVENT DATE, DIAGNOSTIC TESTING, PT DATA, OR FURTHER EVENT DETAILS. SOME OF THE DATA MAY NOT BE AVAILABLE AS THE PATIENT'S RECORDS HAVE BEEN REPORTED AS UNABLE TO BE LOCATED.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTS 'FRACTURE OF THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2797 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR