BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2053446 · Received March 1, 2011

    Report

    Report Number
    2024601-2011-00111
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 18, 2011
    Report Date
    February 4, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2011. 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 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

    ALLERGAN REP REPORTED ON BEHALF OF THE PHYSICIAN AN ALLEGED LAP-BAND "LEAK." F/U FINDINGS: THE PT CAME TO OFFICE AND STATED THAT THEY COULD NO LONGER FEEL RESTRICTION FROM THEIR BAND. A BARIUM SWALLOW WAS PERFORMED. RESULTS SHOWED A LEAK. THE [TUBING] "PRODUCT WAS SHOWN TO HAVE LEAK DURING EXPLANTATION." 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 1708010

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR