BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 4102700 · Received August 28, 2014

    Report

    Report Number
    2024601-2014-00463
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    July 15, 2014
    Report Date
    August 7, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED ON THE IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. 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. FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    COMPANY REP REPORTED THAT THE BAND PORTION OF THE LAP-BAND SYSTEM HAS A "HOLE" IN IT, "UNDER THE BUCKLE". THE PT PRESENTED WITH "SOME ISSUES LAST MONTH" INCLUDING "RESTRICTION ISSUES" AND "UP AND DOWN WITH FLUID". THE ENTIRE LAP-BAND SYSTEM WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526511 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention