BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 1844719 · Received September 22, 2010

    Report

    Report Number
    2024601-2010-00728
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    July 15, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. REFLUX AND VOMITING 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 TO POSSIBLE OUTCOME OF REFLUX AS FOLLOWS: "ULCERATION, GASTRITIS, GASTRO-ESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION, AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF VOMITING AS FOLLOWS: "NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PATIENT EATS MORE THAN RECOMMENDED."

    Description of Event or Problem · 1

    ALLERGAN REPRESENTATIVE RECEIVED A VOICEMAIL MESSAGE FROM A HEALTH PROFESSIONAL REQUESTING A RETURN KIT FOR AN EXPLANTED DEVICE. FOLLOW-UP FINDINGS: "BAND/PORT EXPLANT. PERSISTENT VOMITING WITH BLOOD. NOT ABLE TO KEEP FLUIDS DOWN AND GERD." NO ADDITIONAL INFORMATION AVAILABLE FROM REPORTER, AT THIS TIME. THE DEVICE WAS RETURNED AND IS BEING ANALYZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1706882

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention