BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 2033614 · Received February 11, 2011

    Report

    Report Number
    2024601-2011-00048
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    June 1, 2008
    Report Date
    January 14, 2011
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LTI
    UDI-DI
    10811955020169
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2011. THIS EVENT IS RELATED TO THE SAME PT, BUT A DIFFERENT EVENT INVOLVED IN REPORT # 2024601-2011-00049. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. FURTHER INFO FROM THE REPORTER REGARDING THE SERIAL NUMBER HAS BEEN REQUESTED. 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

    PT HAD A LAP-BAND LEAK THAT WAS CAUSED BY A CRACK IN THE TUBING. THE TUBING WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI ALLERGAN (COSTA RICA) NA 1396074 10811955020169

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention| O| H