BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) ACCESS PORT I

    MDR report key: 1192037 · Received October 6, 2008

    Report

    Report Number
    2024601-2008-00769
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II, THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. 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. EROSION, HEMATOMA AND ESOPHAGEAL PERFORATION ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING SERIAL NUMBER HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF EROSION AS FOLLOWS: "THERE IS A RISK OF BAND EROSION INTO STOMACH TISSUE." "RE-OPERATION TO REMOVE THE DEVICE IS REQUIRED." DEVICE LABELING ADDRESS THE POSSIBLE OUTCOME OF ESOPHAGUS PERFORATION AS FOLLOWS: DISCARD THE CALIBRATION TUBE AFTER USE ONLY WHEN ONE SURGEON HAS COMPLETED SURGERY. DURING INSERTION OF THE CALIBRATION BALLOON, CARE, MUST BE TAKEN TO PREVENT PERFORATION OF THE ESOPHAGUS OR STOMACH.

    Description of Event or Problem · 1

    REPORTED AS THE PATIENT HAD A PORT SITE HEMATOMA. UNDER TREATMENT, THE DOCTOR OBSERVED THE TUBING ERODING INTO THE COLON. ALSO NOTED WAS A SMALL ESOPHAGEAL PERFORATION. THE PATIENT WAS TAKING PREDNISONE (STEROID) WHICH IS A CONTRAINDATION FOR THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) ACCESS PORT I DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention