BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP

    MDR report key: 4938255 · Received July 17, 2015

    Report

    Report Number
    4938255
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    July 11, 2015
    Report Date
    July 17, 2015
    Manufacturer
    ALLERGAN, INC
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS NOTED TO HAVE NAUSEA/VOMITING AND CT REVEALED HER LAP-BAND HAD SLIPPED AND NEEDED IMMEDIATE SURGICAL ATTENTION. PT TAKEN TO OR AND HAD LAP-BAND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465682 LAP-BAND AP IMPLANT, INTRAGASTRIC LTI ALLERGAN, INC B-2240 *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR