BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1193158 · Received October 6, 2008

    Report

    Report Number
    2024601-2008-00773
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 12, 2008
    Manufacturer
    BIOENTERICS CORPORATION
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER I. MEDWATCH SENT TO FDA ON: 10/06/08. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER I. 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. BAND SLIPPAGE, VOMITING, AND NAUSEA ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFO FROM THE REPORTER REGARDING THE SERIAL NUMBER HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING." DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF BAND SLIPPAGE, VOMITING, AND NAUSEA AS FOLLOWS: "SLIPPAGE OF THE BAND CAN OCCUR. GASTROESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE IN SOME CASES SUCCESSFULLY RESOLVED BY BAND DEFLATION. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL."

    Description of Event or Problem · 1

    REPORTED BY COMPANY REPRESENTATIVE AS: "...THIS YEAR (THE PATIENT) STARTED TO HAVE PROBLEMS...AND VOMITED DAILY...SHE WENT TO SEE (PHYSICIAN) WHOM OPERATED ON HER ...AND FOUND THAT THE PORT OF HER BAND WAS BROKEN". REPORTED BY THE PATIENT AS: "...I WAS NAUSEATED AND VOMITED FOR A WEEK...(THE PHYSICIAN) REMOVED THE PORT ONLY AT THIS TIME...HOWEVER, HE WILL EVALUATE AGAIN AND POSSIBLY HAS TO REMOVE THE BAND TOO." FOLLOW-UP WITH THE PATIENT: "I (PATIENT) HAD AN ACCIDENT RECENTLY AND THE BREAKAGE OF THE PORT MAY HAVE BEEN ASSOCIATED WITH THE TRAUMA RESULTING FROM THE ACCIDENT". FOLLOW UP WITH THE SURGEON THROUGH ALLERGAN IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM DEVICE FOR TREATMENT OF MORBID OBESITY LTI BIOENTERICS CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1