BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNKNOWN SIZE)

    MDR report key: 1854239 · Received September 3, 2010

    Report

    Report Number
    2024601-2010-00639
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    April 12, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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

    RECEIVED A VOICEMAIL MESSAGE FROM HEALTH PROFESSIONAL REQUESTING A RETURN KIT FOR AN EXPLANTED DEVICE. IN THE MESSAGE, HEALTH PROFESSIONAL SAID THEY HAVE A LAP-BAND TO RETURN TO ALLERGAN. NO ADD'L INFO WAS PROVIDED. F/U FINDINGS: PFN WAS SENT TO ALLERGAN. EVENT DESCRIPTION STATES: "PORT LEAK." NO INFO IF A REPLACEMENT WAS USED. THE DEVICE WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNKNOWN SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR