BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    MDR report key: 2191254 · Received July 19, 2011

    Report

    Report Number
    2024601-2011-00577
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. 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." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DIFFICULTY ADDING/REMOVING SALINE AS FOLLOW: "IT IS IMPORTANT TO REMOVE ANY ADDITIONAL SALINE VIA THE ACCESS PORT SO NO AIR WILL ENTER THE LAP-BAND SYSTEM, COMPROMISING LATER ADJUSTMENTS. CAUTION: FAILURE TO CREATE A STABLE, SMOOTH PATH FOR THE ACCESS PORT TUBING, WITHOUT SHARP TURNS OR BENDS, CAN RESULT IN TUBING BREAKS AND LEAKAGE."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED THE EXPLANTATION OF A LAP-BAND SYSTEM DUE TO ALLEGED "COMPROMISE OF THE LAP BAND SYSTEM" NOTED FROM "DIFFICULTIES WITH...LAP BAND ADJUSTMENTS." "SEROUS, YELLOWISH COLORED FLUID ASPIRATE FROM...LAP BAND," AND "THE LAP BAND TUBING, BETWEEN BAND AND PORT, DID IN FACT HAVE A SLIT IN IT WHICH ALLOWED FLUID TO LEAK OUT." THE ENTIRE SYSTEM WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM LTI ALLERGAN NA S02LB159

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR NONE REPORTED.