BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE FASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 3130252 · Received May 22, 2013

    Report

    Report Number
    2024601-2013-00458
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    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 EZ 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 ADDITIONAL INFORMATION WILL BE REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR MODEL NUMBER, AS IT IS NOT KNOWN TO THE EXPLANT FACILITY. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED "PORT BECAME DISCONNECTED." BREAKAGE NOTED AS "FRACTURE AT TUBE AND CONNECTOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227783 LAP-BAND ADJUSTABLE FASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR