BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 2841940 · Received November 14, 2012

    Report

    Report Number
    2024601-2012-01184
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE ACCESS PORT CONNECTOR ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AND MAY HAVE BEEN DISCARDED AFTER SURGERY BY THE EXPLANT FACILITY. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE EXPLANT FACILITY MAY HAVE DISCARDED THE DEVICE WHEN IT WAS EXPLANTED AND IT IS NO LONGER AVAILABLE FOR RETURN. THEREFORE ALLERGAN WILL NOT RECEIVE IT AND NO ANALYSIS OR TESTING WILL BE DONE. INFECTION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE REPORTER HAS DECLINED TO PROVIDE ALLERGAN FURTHER INFORMATION OR TO ALLOW ALLERGAN TO CONTACT THE EXPLANT FACILITY OR THE PATIENT. NO ADDITIONAL INFORMATION REGARDING THE EVENT, CAUSALITY EXPLANT DATE OR PATIENT DATA WILL BE AVAILABLE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN INFECTION AS FOLLOWS: "INFECTION CAN OCCUR IN THE IMMEDIATE POST-OPERATIVE PERIOD OR YEARS AFTER INSERTION OF THE DEVICE. IN THE PRESENCE OF INFECTION OR CONTAMINATION, REMOVAL OF THE DEVICE IS INDICATED."

    Description of Event or Problem · 1

    TREATING PHYSICIAN REPORTED A PATIENT DEVELOPED A POST-OPERATIVE PORT SITE INFECTION AND HAD TO HAVE TO PORT REMOVED WITH THE TUBING BEING PLACED BACK IN THE ABDOMINAL CAVITY. FOLLOW-UP FINDINGS: NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE REPORTER AND ALLERGAN HAS BEEN DIRECTED NOT TO CONTACT THIRD-PARTIES REGARDING THIS EVENT FOR OUR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA 1719411

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention