BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP BAND

    MDR report key: 3030020 · Received March 28, 2013

    Report

    Report Number
    3030020
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ALLERGAN INC.
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LAP BAND PLACED AT OUTSIDE HOSPITAL. DEVICE LOT#, CATALOG # AND EXACT DATE OF IMPLANT UNKNOWN. ESTIMATED THE BAND WAS PLACED THREE YEARS AGO. SUDDEN ONSET OF PAIN AND PATIENT PRESENTED TO THE ED. PT INFORMED THAT THE GASTRIC BAND WAS DISCONNECTED AT THAT TIME. TO OR TO REMOVE FRACTURED TUBING AND PORT APPROXIMATELY 5 MONTHS AFTER ED VISIT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127676 LAP BAND IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI ALLERGAN INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR