BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 2062875 · Received March 18, 2011

    Report

    Report Number
    2024601-2011-00166
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    January 1, 2009
    Report Date
    February 22, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2011. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED AS THE DEVICE WAS NOT EXPLANTED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. 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, AN ALLEGED LAP-BAND PORT LEAK AFTER TWO UNSUCCESSFUL FILLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR THE PATIENT IS CURRENTLY TAKING INSULIN,| RAMIPRIL| PREVISTATIN,| ADDERAL