BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 3770273 · Received February 18, 2014

    Report

    Report Number
    2024601-2014-00063
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    February 16, 2014
    Report Date
    January 23, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS NOT BEEN COMPLETED AT THIS TIME. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR MODEL NUMBER. THIS INFORMATION IS NOT AVAILABLE TO THE EXPLANT FACILITY, AS THE DEVICE WAS IMPLANTED IN ANOTHER FACILITY.

    Description of Event or Problem · 1

    EXPLANTING PHYSICIAN REPORTS, 'SLOW LEAK. REPLACE. VERY SMALL HOLE A JUNCTION OF PORT AND PORT TUBING'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101762 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR