BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 2010903 · Received March 4, 2011

    Report

    Report Number
    2024601-2011-00115
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    November 12, 2010
    Report Date
    February 3, 2011
    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. DEHYDRATION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. ANALYSIS SHOWED A THINNER SURFACE ON THE TAPER TUBING JUNCTION AND A SMOOTH OPENING CONSISTENT WITH WEAR AND TEAR. THE ACCESS PORT AND PORT TUBING HAD NON-PENETRATING NICKS WITH STRIATIONS DESCRIBED AS SURGICAL TOOL SCRATCH-LIKE. THE DAMAGED PORT SEPTUM HAD MISSING MATERIAL WITH EVIDENCE OF CORING LIKELY TO HAVE BEEN CAUSED BY THE USE OF A CORING NEEDLE. THE BUCKLE WAS BROKEN WITH STRIATIONS CONSISTENT WITH A SURGICAL END CUT TO REMOVE THE DEVICE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF DEHYDRATION 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 A LAP-BAND DEVICE WAS REMOVED "DUE TO BEING ADMITTED INTO THE HOSPITAL FOR DEHYDRATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA 1037802

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention