BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1930697 · Received December 14, 2010

    Report

    Report Number
    2024601-2010-00966
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 26, 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

    (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER 1. ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR THE IMPLANT DATE. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AS FOLLOWS: "THERE WERE ADDITIONAL OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYS THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ¿ABDOMINAL PAIN, DEHYDRATION, CHEST PAIN, INCISION PAIN, AND¿ PORT SITE PAIN." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF DYSPHAGIA 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

    COMPANY REPRESENTATIVE REPORTED ON BEHALF OF A HEALTH PROFESSIONAL, THE RETURN OF AN EXPLANTED LAP-BAND DEVICE. THE ADVERSE EVENT IS UNK. FURTHER F/U WITH A HEALTH PROFESSIONAL NOTED THE DEVICE WAS EXPLANTED, BECAUSE THE PT BEGAN EXPERIENCING DYSPHAGIA AND UPPERGASTRIC PAIN.

    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 48 YR Required Intervention