BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AP LRG W/RAPIDPORT EZ

    MDR report key: 2013272 · Received March 8, 2011

    Report

    Report Number
    2024601-2011-00129
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    January 5, 2011
    Report Date
    February 8, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RAPID PORT EZ STRAIN RELIEF. (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A RAPID PORT EZ STRAIN RELIEF. ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DISPLACEMENT AS FOLLOWS: "CARE MUST BE TAKEN TO PLACE THE ACCESS PORT IN A STABLE POSITION AWAY FROM AREAS THAT MAY BE AFFECTED BY SIGNIFICANT WEIGHT LOSS, PHYSICAL ACTIVITY, OR SUBSEQUENT SURGERY. MIGRATION OF THE BAND AND/OR TIPPING OF THE ACCESS PORT CAN OCCUR, RESULTING IN REDUCED WEIGHT LOSS, WEIGHT GAIN OR OTHER COMPLICATIONS, AND POSSIBLE REOPERATION TO REMOVE OR REPOSITION THE DEVICE."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED DISPLACEMENT WITH AN EZ PORT ACCESS PORT OF A LAP-BAND DEVICE. THE PORT WAS EXPLANTED BECAUSE THE "PORT HAD FLIPPED." "DURING THE 2ND FILL APPOINTMENT, THE PT COMPLAINED OF DECREASED SATIETY AND RESTRICTION. THE DOCTOR FOUND AN ADJUSTMENT COULDN'T BE DONE." A FLUOROSCOPY WAS PERFORMED AND THE DOCTOR SAW THE PORT HAD FLIPPED. DURING EXPLANT SURGERY THE PORT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AP LRG W/RAPIDPORT EZ LTI ALLERGAN NA 1850453

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention NONE REPORTED