BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2862140 · Received November 29, 2012

    Report

    Report Number
    2024601-2012-01248
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    March 1, 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) 2012. THE PRODUCT ASSOCIATED WITH THIS REPORT WAS RETURNED, HOWEVER, THE DEVICE ANALYSIS HAS NOT BEEN STARTED AT THIS TIME. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A STRAIN RELIEF. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER HAS DECLINED TO PROVIDE ALLERGAN FURTHER INFORMATION REGARDING THE SERIAL NUMBER, MODEL NUMBER, DIAGNOSTIC TESTING OR PATIENT DATA. 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 AS - CATHETER LEAKAGE, NOTED AT THE PORT TUBING JUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR