BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AP LRG W/RAPIDPORT EZ

    MDR report key: 2023233 · Received February 15, 2011

    Report

    Report Number
    2024601-2011-00152
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 7, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(6) 2011. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A RAPID PORT EZ STRAIN RELIEF. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. INFECTION, DYSPHAGIA, AND PAIN ARE SURGICAL AND PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN INFECTION, DYSPHAGIA, AND PAIN 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. ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ... ABDOMINAL PAIN."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED A LAP-BAND REMOVAL. ABOUT ONE WEEK AFTER THE INITIAL IMPLANTATION, THE PT HAD EXPERIENCED ABDOMINAL PAIN AND DYSPHASIA. THE SURGEON TREATED THESE EVENTS BY REMOVING FLUID A COUPLE OF TIMES WITHOUT RESOLUTION. THE ENTIRE SYSTEM WAS REMOVED WITHOUT REPLACEMENT WHEN THE PT PRESENTED WITH AN INFECTION, ALSO ABOUT ONE WEEK AFTER IMPLANTATION. THE SURGEON PERFORMED A CAT SCAN AND ESOPHAGOGASTRODUODENOSCOPY WHICH "VERIFIED THE PROBABILITY OF AN INFECTION." A CULTURE OF THE INFECTION WAS TAKEN. F/U FINDINGS: INFECTION CULTURE RESULTS SHOWED (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AP LRG W/RAPIDPORT EZ LTI ALLERGAN NA 2054397

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE REPORTED.