BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    MDR report key: 3881634 · Received April 8, 2014

    Report

    Report Number
    2024601-2014-00179
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    January 15, 2014
    Report Date
    March 13, 2014
    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

    TAPER I. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER I. ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    PHYSICIAN REPORTS A LEAK OF THE ACCESS PORT, NOTED ON THE TAPER I CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212305 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM LTI ALLERGAN NA S99LB542

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR