BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2050794 · Received April 1, 2011

    Report

    Report Number
    2024601-2011-00228
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(6) 2011. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE 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. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR THE ACTUAL IMPLANT DATE. DEVICE LABELLING ADDRESSES THE POSSIBLE OUTCOME OF EROSION AS FOLLOWS: "THERE IS A RISK OF BAND EROSION INTO STOMACH TISSUE." "RE-OPERATION TO REMOVE THE DEVICE IS REQUIRED."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED EXPLANTATION OF A LAP-BAND DUE TO EROSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention