BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2100795 · Received May 19, 2011

    Report

    Report Number
    2024601-2011-00366
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 19, 2011
    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

    MEDWATCH SENT TO FDA ON: (B)(4) 2011. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. REFLUX IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. ANALYSIS NOTED THE PORT TUBING AND ACCESS PORT HAD NON-PENETRATING NICKS WITH STRIATIONS DESCRIBED AS SURGICAL TOOL SCRATCH-LIKE. THE PORT TUBING ALSO HAD EVIDENCE OF MISSING MATERIAL. THE DAMAGED PORT SEPTUM HAD PULLED MATERIAL WITH EVIDENCE OF CORING LIKELY TO HAVE BEEN CAUSED BY THE USE OF A CORING NEEDLE. THE BAND TUBING WAS BROKEN WITH STRIATIONS CONSISTENT WITH A SURGICAL END CUT TO REMOVE THE DEVICE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF REFLUX 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 "BAND/PORT REMOVAL DUE TO BAD REFLUX W/EMPTY BAND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1449171

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention