BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1895325 · Received November 2, 2010

    Report

    Report Number
    2024601-2010-00895
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER I. (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. REFLUX IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. ANALYSIS OF THE SHELL NOTED AN UNIDENTIFIED SHARP, CURVED OPENING WITH LEAKAGE. THE BAND TUBING AND BUCKLE WERE BROKEN WITH STRIATIONS CONSISTENT WITH A SURGICAL END CUT TO REMOVE THE DEVICE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF REFLUX AS FOLLOWS: "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED THAT THERE WAS AN EXPLANTED DEVICE IN THEIR POSSESSION THAT NEEDED TO BE RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED. FURTHER FOLLOW-UP WITH THE HEALTH PROFESSIONAL NOTED "BAND/PORT EXPLANT DUE TO REFLUX."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention