BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2151168 · Received June 21, 2011

    Report

    Report Number
    2024601-2011-00515
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 14, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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

    AN EXPLANTED LAP-BAND SYSTEM WAS RETURNED TO ALLERGAN DEVICE ANALYSIS LAB BY THE PHYSICIAN WHO ENCLOSED A REPORT STATING, "SURGEON SUSPECTED BAND TO BE DEFECTIVE SO...REPLACED IT..." NO ADDITIONAL DETAILS ABOUT THE EVENT WAS PROVIDED. FOLLOW UP IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 2104590

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR NONE REPORTED.