BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AP STD, ACCESS PORT KIT RAPIDPORT EZ

    MDR report key: 1884949 · Received October 21, 2010

    Report

    Report Number
    2024601-2010-00857
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    June 19, 2010
    Report Date
    July 6, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. INFECTION, EROSION, AND CELLULITIS ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF INFECTION AND CELLULITIS AS FOLLOWS: "INFECTION CAN OCCUR IN THE IMMEDIATE POST-OPERATIVE PERIOD OR YEARS AFTER INSERTION OF THE DEVICE. IN THE PRESENCE OF INFECTION OR CONTAMINATION, REMOVAL OF THE DEVICE IS INDICATED." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF EROSION AS FOLLOWS: "AS WITH OTHER GASTROPLASTY SURGERIES, PARTICULAR CARE MUST BE TAKEN DURING DISSECTION AND DURING IMPLANTATION OF THE DEVICE TO AVOID DAMAGE TO THE GASTROINTESTINAL TRACT. ANY DAMAGE TO THE STOMACH DURING THE PROCEDURE MAY RESULT IN EROSION OF THE DEVICE INTO THE GI TRACT." "OVER-DISSECTION OF THE STOMACH DURING PLACEMENT MAY RESULT IN SLIPPAGE OR EROSION OF THE BAND AND REQUIRE REOPERATION." "THERE IS A RISK OF BAND EROSION INTO STOMACH TISSUE. EROSION OF THE BAND INTO STOMACH TISSUE HAS BEEN ASSOCIATED WITH REVISION SURGERY AFTER THE USE OF GASTRIC-IRRITATING MEDICATIONS, AFTER STOMACH DAMAGE AND AFTER EXTENSIVE DISSECTION OR USE OF ELECTROCAUTERY, AND DURING EARLY EXPERIENCE.

    Description of Event or Problem · 1

    PT DIAGNOSED WITH DEEP SOFT TISSUE INFECTION AROUND PORT. PT WAS ADMITTED TO HOSPITAL AND HAD TO HAVE SURGERY TO REMOVE THE INFECTED PORT. PT HAD SUBSEQUENT SERIOUS ADVERSE EVENT (SAE) OF CELLULITIS, AND AN ENDOSCOPY PERFORMED SHOWED BAND EROSION AROUND STOMACH. THE LAP-BAND (R) WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AP STD, ACCESS PORT KIT RAPIDPORT EZ LTI ALLERGAN NA 1823828

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R