BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 3770256 · Received February 18, 2014

    Report

    Report Number
    2024601-2014-00059
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 21, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 HAS NOT BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER, SERIAL 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 INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE DIAGNOSTIC TESTING, PATIENT DATA OR FURTHER EVENT DETAILS.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED WHEN REMOVING THE OLD PORT, OBSERVATION OF A CLEAR SECTION OF THE TUBING OF THE DEVICE, WHICH NOT ALLOWS TO CONNECT THE NEW PORT. THE BAND TUBING WAS NOTED WITH THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101308 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 1763468

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR