BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 3140049 · Received May 29, 2013

    Report

    Report Number
    2024601-2013-00445
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    January 8, 2013
    Report Date
    February 18, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER, THE EVENT DATE, DIAGNOSTIC TESTING OR ADDITIONAL PT DATA. 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

    NO INFO REGARDING THIS EVENT: FOLLOW-UP FINDINGS: DEVICE RECEIVED AT THE DEVICE ANALYSIS LAB WITH THIS NOTATION "PT ADMITTED... FOR REPLACEMENT AND REPORT TUBING." AND A NOTATION WAS WRITTEN, "FRACTURE OF TUBE AT INTERCONNECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234445 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR