BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLERGAN

    MDR report key: 2141214 · Received June 15, 2011

    Report

    Report Number
    2141214
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ALLERGAN, INC.
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    THE PT HAD BEEN EXPERIENCING DIFFICULTIES WITH HER LAP BAND ADJUSTMENTS DURING OUTPATIENT APPOINTMENTS AT THE BARIATRIC OFFICE. UPON PT'S LAST ADJUSTMENT, THE MD NOTED SEROUS, YELLOWISH COLORED FLUID ASPIRATE FROM HER LAP BAND WHICH LED HIM TO BELIEVE THERE MAY HAVE BEEN A COMPROMISE OF THE LAP BAND SYSTEM. THE PT WAS SCHEDULED FOR SURGERY. THE SURGEON WAS ABLE TO CONFIRM THE LAP BAND TUBING, BETWEEN BAND AND PORT, DID IN FACT HAVE A SLIT IN IT WHICH ALLOWED FLUID TO LEAK OUT. THE SURGEON REMOVED THE ENTIRE SYSTEM AND REPLACED IT WITH A NEW ONE AS THE PT HAD REQUESTED. THE PT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGAN ALLERGAN LAP BAND SYSTEM LTI ALLERGAN, INC. B-2210 *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR