BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 2041108 · Received March 29, 2011

    Report

    Report Number
    2024601-2011-00242
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    January 18, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT. BASED UPON THE MODEL NUMBER PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAM MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. ESOPHAGEAL DILATATION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF ESOPHAGEAL DILATATION AS FOLLOWS: "ESOPHAGEAL DISTENTION OR DILATATION HAS BEEN REPORTED INFREQUENTLY. THIS IS MOST LIKELY A CONSEQUENCE OF INCORRECT BAND PLACEMENT, OVER-RESTRICTION, STOMA OBSTRUCTION, AND CAN ALSO BE DUE TO EXCESSIVE VOMITING, OR PT NON-COMPLIANCE, AND MAY MORE LIKELY IN CASES OF PRE-EXISTING ESOPHAGEAL DYSMOTILITY. DEFLATION OF THE BAND IS RECOMMENDED IF ESOPHAGEAL DILATATION DEVELOPS. A REVISION PROCEDURE MAY BE NECESSARY TO RE-POSITION OR REMOVE THE BAND IF DEFLATION DOES NOT RESOLVE THE DILATION."

    Description of Event or Problem · 1

    DOCTOR REPORTED AN EVENT OF "ESOPHAGEAL DILATATION." A LAP-BAND AP SYSTEM REMOVAL TOOK PLACE TO TREAT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN N/A 1817649

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R