BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 1841197 · Received September 13, 2010

    Report

    Report Number
    2024601-2010-00709
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN UNBUCKLED BAND AS FOLLOWS: WARNING: "FAILURE TO SECURE THE BAND PROPERLY MAY RESULT IN IT SUBSEQUENT DISPLACEMENT AND NECESSITATE RE-OPERATION." CAUTION: "FAILURE TO USE AN APPROPRIATE ATRAUMATIC INSTRUMENT SUCH AS THE LAP-BAND SYSTEM CLOSURE TOOL TO LOCK THE BAND MAY RESULT IN DAMAGE TO THE BAND OR INJURY TO SURROUNDING TISSUES." "THE MANUFACTURER OF THE LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM HAS DESIGNED, TESTED AND MANUFACTURED IT TO BE REASONABLY FIT FOR ITS INTENDED USE. HOWEVER, THE LAP-BAND AP SYSTEM IS NOT A LIFETIME PRODUCT AND IT MAY BREAK OR FAIL, IN WHOLE OR IN PART, AT ANY TIME AFTER IMPLANTATION AND NOTWITHSTANDING THE ABSENCE OF ANY DEFECT. CAUSES OF PARTIAL OR COMPLETE FAILURE INCLUDE, WITHOUT LIMITATION, EXPECTED OR UNEXPECTED BODILY REACTIONS TO THE PRESENCE AND POSITION OF THE IMPLANTED DEVICE, RARE OR ATYPICAL MEDICAL COMPLICATIONS, COMPONENT FAILURE AND NORMAL WEAR AND TEAR. IN ADDITION, THE LAP-BAND AP SYSTEM MAY BE EASILY DAMAGED BY IMPROPER HANDLING OR USE."

    Description of Event or Problem · 1

    THEATRE NURSE CONTACTED ALLERGAN FOR SURGEON TO REPORT AN APS LAP-BAND SYSTEM THAT HAD A BUCKLE BREAKAGE IN SITU AND WAS EXPLANTED IN LESS THAN ONE MONTH AFTER IMPLANTATION. THE PATIENT HAD NO FOOD RESTRICTION FROM IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 1829275

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention