BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 1915249 · Received November 2, 2010

    Report

    Report Number
    2024601-2010-00859
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    June 5, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (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. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DIFFICULTY ADDING AND/OR REMOVING SALINE AS FOLLOWS: "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

    MEDICAL STAFF CALLED AND REPORTED AN ALLEGED "BROKEN PORT" DESCRIBED AS DIFFICULTY FILLING AND REMOVING SALINE FROM THE DEVICE. THE PORT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1636929

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR