BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNKNOWN SIZE)

    MDR report key: 1993803 · Received January 13, 2011

    Report

    Report Number
    2024601-2010-01083
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    November 23, 2010
    Report Date
    December 29, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4) 2011. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED AS THE DEVICE WAS NOT EXPLANTED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. NO ADD'L INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. 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 AN ALLEGED "BROKEN TUBING". THE DEVICE WAS FOUND TO HAVE A "LEAK" WHEN THE DR PERFORMED A FLUOROSCOPY AND FOUND THE TUBING HAD A HOLE IN IT. THE TUBING WAS RECONNECTED AND THE DEVICE REMAINS IMPLANTED.

    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 35 YR