BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 3133204 · Received May 24, 2013

    Report

    Report Number
    2024601-2013-00406
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    August 11, 2010
    Report Date
    April 11, 2013
    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 FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE 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. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. PAIN IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE REPORTED EVENT AND IF THE DEVICE IS AVAILABLE FOR RETURN 16 MONTHS AFTER EXPLANTATION. SEE RELATED MEDWATCH REPORT #2024601-2013-00297. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AS FOLLOWS: "11. PATIENTS MUST BE CAREFULLY COUNSELED ON THE NEED TO REPORT ALL VOMITING, ABDOMINAL PAIN OR OTHER GASTROINTESTINAL OR NUTRITIONAL ISSUES AS THESE SYMPTOMS MAY INDICATE A CONDITION NOT RELATED TO THE LAP-BAND SYSTEM."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED ORIGINAL ACCESS PORT REMOVED AND REPLACED 14 MONTHS PREVIOUSLY FOR AN UNSPECIFIED REASON. FOLLOW-UP FINDINGS: THE PORT WAS REMOVED FOR PAIN AROUND ACCESS PORT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232172 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 1764530

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR NO CONCOMITANT THERAPY PER PHYSICIAN