BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INAMED

    MDR report key: 1052130 · Received May 22, 2008

    Report

    Report Number
    MW5007011
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 22, 2008
    Manufacturer
    INAMED
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2007, THE PATIENT HAD A LAP BAND PROCEDURE. SHE HAD VERY GOOD WEIGHT LOSS APPROXIMATELY 80 POUNDS. SHE BEGAN TO DEVELOP A LEAK IN HER BAND WHICH WOULD NOT HOLD SALINE. THE PATIENT UNDERWENT A FILL IN 2008 AT WHICH TIME THERE WAS NO SALINE THAT WAS ABLE TO BE WITHDRAWN PRIOR TO HER FILL. SHE WAS FILLED TO 2.7 AND HAD A GOOD RESTRICTION. WITHIN 3 TO 4 DAYS OF THIS FILL THE PATIENT STATED SHE HAD NO RESTRICTION. ON EIGHT DAYS LATER, THE PATIENT UNDERWENT A FLUOROSCOPY. THE SOURCE WAS UNABLE TO BE IDENTIFIED; THEREFORE, SURGERY FOR REPLACEMENT WAS DONE ON APPROX ONE AND A HALF MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INAMED BIOENTERICS ADJUSTABLE LAP BAND LTI INAMED SIZE 10 CM 12706034

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Disability