BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1841345 · Received September 13, 2010

    Report

    Report Number
    2024601-2010-00662
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    March 15, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 REC'D THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. DYSPHAGIA IS A SURGICAL AND PHYSIOLOGICAL COMPLICATION, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF DYSPHAGIA AS FOLLOWS: "ULCERATION, GASTRITIS, GASTRO-ESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES."

    Description of Event or Problem · 1

    ALLERGAN REP REC'D A VOICEMAIL MESSAGE FROM A HEALTH PROFESSIONAL REQUESTING A RETURN KIT FOR AN EXPLANTED DEVICE TO BE ABLE TO RETURN THE PRODUCT TO ALLERGAN. NO ADD'L INFO WAS PROVIDED. F/U FINDINGS: PFN WAS REC'D BY ALLERGAN. EVENT DESCRIPTION STATES: "BAND EXPLANT DUE TO DYSPHASIA." THE DEVICE WAS RETURNED AND ANALYZED. THE SERIAL NUMBER OF THE DEVICE WAS NOT AVAILABLE FROM THE SURGEON.

    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 45 YR Required Intervention