BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2013246 · Received March 8, 2011

    Report

    Report Number
    2024601-2011-00143
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, THE DATE OF THE EVENT, AND THE IMPLANT AND EXPLANT DATES. THIS INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. 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. INFECTION IS A SURGICAL AND PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFO FROM THE REPORTER REGARDING THE SERIAL NUMBER AND THE IMPLANT DATE HAS BEEN REQUESTED. 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

    HEALTH PROFESSIONAL REPORTED A LAP-BAND DEVICE PRESENTED "INFECTED FLUID INSIDE THE PORT/TUBING." THE DOCTOR "TOOK OFF THE PORT AND FLUSHED THE TUBING OUT WITH PEROXIDE AND WITH SALINE AND BP SOLUTION AND ACTUALLY LEFT SOME BP SOLUTION IN THE TUBING, PLUGGED IT AND THE PT HAS DONE WELL AND RECOVERED." FOLLOW-UP WITH THE SURGEON IS IN PROGRESS. AT THIS TIME, ALLERGAN HAS NOT RECEIVED ADDITIONAL INFO. PER THE INITIAL REPORT TO ALLERGAN, THE DEVICE REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention