BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 2080436 · Received April 22, 2011

    Report

    Report Number
    2024601-2011-00269
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. BAND SLIPPAGE AND REFLUX ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF BAND SLIPPAGE AS FOLLOWS: "SLIPPAGE OF THE BAND CAN OCCUR. GASTROESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE IN SOME CASES SUCCESSFULLY RESOLVED BY BAND DEFLATION. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL." 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

    COMPANY REPRESENTATIVE REPORTED ON BEHALF OF THE PHYSICIAN AN ALLEGED BAND SLIPPAGE. ADDITIONALLY, THE OPERATIVE REPORT INDICATED ALLEGED THE PT ALSO HAD "SEVERE REFLUX."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA 1063866

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention