BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 1920181 · Received December 8, 2010

    Report

    Report Number
    2024601-2010-00999
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. EROSION, VOMITING, AND PAIN ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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." DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF VOMITING AS FOLLOWS: "VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PT EATS MORE THAN RECOMMENDED." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AS FOLLOWS: "OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ESOPHAGITIS, GASTRITIS, HIATAL HERNIA, PANCREATITIS, ABDOMINAL PAIN, HERNIA, INCISIONAL INFECTION..."

    Description of Event or Problem · 1

    DOCTOR REPORTED EVENTS OF "PAIN, EROSION AND VOMIT." DOCTOR PERFORMED A SURGERY TO EXPLANT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1470372

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R