BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 1993892 · Received January 13, 2011

    Report

    Report Number
    2024601-2010-01072
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    September 15, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. 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 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

    HEALTH PROFESSIONAL REPORTED A LAP-BAND PORT HAD BEEN REMOVED AS THERE WAS A "LEAK IN PORT." THE PT COMPLAINED OF FEELING "SIGNIFICANT HUNGER AND LACK OF RESTRICTION." "UPON ACCESSING THE PORT," IT WAS NOTICED THERE WAS "LESS FLUID THAN EXPECTED IN THE BAND." EXAMINATION OF THE EXPLANTED "PORT, ENTIRE TUBING AND BAND," SHOWED "A POSSIBLE AREA OF EXTRAVASATION ALONG THE LATERAL ASPECT OF THE PROXIMAL TUBING." THE PORT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1754880

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR NONE REPORTED.