BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 2862120 · Received November 29, 2012

    Report

    Report Number
    2024601-2012-01251
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    January 25, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED BY ALLERGAN, HOWEVER, THE DEVICE ANALYSIS HAS NOT BEEN STARTED AT THIS TIME. BASED UPON THE MODEL NUMBER AND SERIAL NUMBER PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER HAS DECLINED TO PROVIDE ALLERGAN FURTHER INFORMATION REGARDING THE IMPLANT DATE OR DIAGNOSTIC TESTING. 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

    REPORTED BY HEALTH PROFESSIONAL (B)(6) - LEAKAGE OF THE BAND, NOTED IN THE SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA 1797299

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR