BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 3980471 · Received June 5, 2014

    Report

    Report Number
    2024601-2014-00306
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    January 1, 2013
    Report Date
    May 16, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNKNOWN. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, AND IMPLANT DATE. THE INFORMATION HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED A LAP-BAND PORT "NOT HOLDING LIQUID" FIRST NOTICED WHEN THE PATIENT EXPERIENCED "NO RESTRICTION." THE PATIENT STATED THAT WHEN THE PORT WAS REMOVED THE DOCTOR STATED THAT THE PORT WAS "CRACKED." THE LAP-BAND PORT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329876 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR