BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    MDR report key: 2010925 · Received March 4, 2011

    Report

    Report Number
    2024601-2011-00118
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    November 22, 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. VOMITING AND INTOLERANCE ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. ANALYSIS NOTED THE DAMAGED PORT SEPTUM HAD MISSING MATERIAL AND PULLED MATERIAL WITH EVIDENCE OF CORING LIKELY TO HAVE BEEN CAUSED BY THE USE OF A CORING NEEDLE. THE ACCESS PORT HAD NON-PENETRATING NICKS WITH STRIATIONS DESCRIBED AS SURGICAL TOOL SCRATCH-LIKE. THE BAND TUBING AND BUCKLE WERE BROKEN WITH STRIATIONS CONSISTENT WITH A SURGICAL END CUT TO REMOVE THE DEVICE. DEVICE LABELING ADDRESSES THE REPORTED EVENTS 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

    HEALTH PROFESSIONAL REPORTED THE EXPLANT OF A LAP-BAND DUE TO "VOMITING AND DIFFICULTY TOLERATING BAND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG LTI ALLERGAN NA 1161710

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention