BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2095528 · Received April 26, 2011

    Report

    Report Number
    2024601-2011-00355
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    February 19, 2010
    Report Date
    March 29, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2011. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE INFORMATION HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE DATE SPAN OF THE STUDY 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. ALLERGAN HAD NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF LEAK 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

    REPORTED EVENTS OF "PORT PROBLEMS" FROM JOURNAL ARTICLE: "SAFETY, EFFICACY, AND DURABILITY OF LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING IN A SINGLE SURGEON U.S. COMMUNITY PRACTICE", SURGERY FOR OBESITY AND RELATED DISEASES (2011) 140-144. THIS MEDWATCH REPRESENTS THE 14 PTS MENTIONED IN THE ARTICLE WHO WERE DIAGNOSED WITH "PORT PROBLEMS."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention