BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2033579 · Received February 11, 2011

    Report

    Report Number
    2024601-2011-00056
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    June 1, 2010
    Report Date
    January 18, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2011. THIS EVENT IS RELATED TO THE SAME PATIENT, BUT A DIFFERENT EVENT INVOLVED IN REPORT # 2024601-2011-00055. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON PARTIAL 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 INFORMATION FROM THE REPORTER REGARDING THE SERIAL NUMBER AND THE ACTUAL IMPLANT DATE 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

    PATIENT REPORTED "THE TUBING GOING FROM THE BAND ITSELF TO THE PORT HAS BROKEN." THE PATIENT HAD A SIMILAR REPLACEMENT SURGERY PERFORMED ABOUT ONE AND A HALF YEARS EARLIER FOR THE SAME ALLEGED ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI