BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 1994392 · Received January 14, 2011

    Report

    Report Number
    2024601-2010-01069
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    August 1, 2010
    Report Date
    December 17, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4) 2010. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS REC'D THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. 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

    HEALTH PROFESSIONAL REPORTED A "LAP-BAND PORT LEAK". THE SURGEON NOTED THE "LEAKING PORT" WHEN THERE WAS "LESS FLUID EXTRACTED THAN WHAT [PRIOR] WAS RECORDED." THE PORT WAS REMOVED AND REPLACED. F/U FINDINGS: A "BARIUM SWALLOW" TEST WAS PERFORMED AND "IT SHOWED THE LEAK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1637108

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR NONE REPORTED.