BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ACCESS PORT KIT (UNK SIZE)

    MDR report key: 4173505 · Received October 10, 2014

    Report

    Report Number
    2024601-2014-00571
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 18, 2013
    Report Date
    September 15, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P00008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A LAP-BAND PORT WITH "A LEAK AT TUBING CONNECTION," FIRST NOTICED WHEN THE PT "LOST RESTRICTION." THE LAP-BAND PORT WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642829 LAP-BAND ACCESS PORT KIT (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR