BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 3131225 · Received May 23, 2013

    Report

    Report Number
    2024601-2013-00426
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    February 12, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 I. ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. NO ADD'L INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR MODEL NUMBER. 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

    HEALTHCARE PROFESSIONAL REPORTED A LEAKAGE OF THE PORT, NOTED AT THE TAPER TUBING CONNECTOR. THE PORT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228535 LAP BAND ADJUSTABLE GASTRIC BANDING SYSTEM LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR