BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 3940409 · Received June 18, 2014

    Report

    Report Number
    2024601-2014-00319
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACCESS PORT ASSOCIATED WITH THIS REPORT WAS NOT RETURNED AS THE ACCESS PORT WAS NOT EXPLANTED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, IF IT IS EXPLANTED IN THE FUTURE. IT WAS REPOSITIONED DURING THE PROCEDURE AND ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR MODEL NUMBER.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED A LAP-BAND PORT "OBSTRUCTION WITH TOO MUCH FLUIDS" FIRST NOTICED WHEN THE PT WAS PRESENTED WITH NAUSEA AND VOMITING. IT IS NOT KNOWN IF THE LAP-BAND PORT WILL BE REMOVED OR REPLACED. FOLLOW-UP FINDINGS: LAP-BAND PORT WAS NOT EXPLANTED. IT HAS BEEN REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358114 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention