BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 3609016 · Received January 28, 2014

    Report

    Report Number
    2024601-2014-00012
    Event Type
    Injury
    Date Received
    January 28, 2014
    Date of Event
    March 1, 2012
    Report Date
    December 31, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. BASED ON THE IMPLANT DATE, THE TAPER TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION 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. OBSTRUCTION, BOWEL/GASTRIC PERFORATION, DEHYDRATION, VOMITING, ABDOMINAL PAIN, FEVER AND INFECTION ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 1

    REPORTED EVENTS OF EVENTS OF "SEVERE VOMITING", ABDOMINAL PAIN, LOW-GRADE FEVER, DEHYDRATION, "DILATED BOWEL LOOPS", "FREE INTRA-ABDOMINAL BOWEL LOOPS", "FREE PUS", "FECAL MATERIAL IN THE ABDOMINAL CAVITY", PARTIAL BOWEL OBSTRUCTION, AND TWO BOWEL PERFORATIONS WITHIN ONE PT FROM JOURNAL ARTICLE: "LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING CONNECTING TUBE CAUSING SMALL BOWEL OBSTRUCTION AND PERFORATION", HINDAWI PUBLISHING CORPORATION, CASE REPORTS IN SURGERY, VOL. 2013, ARTICLE ID 296037, 3 PAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60287 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 1767209

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R