BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2844608 · Received November 16, 2012

    Report

    Report Number
    2024601-2012-01221
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    September 15, 2012
    Report Date
    October 19, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. (B)(4). NO CONTACT INFO IS AVAILABLE TO ALLERGAN, AT THIS TIME, TO ASK THE REPORTER FOR THE RETURN OF THE PRODUCT FOR ANALYSIS, TO INDICATE THE PRODUCT SERIAL NUMBER, THE DATE OF THE EVENT, AND THE IMPLANT AND EXPLANT DATES. ALLERGAN WILL CONTINUE ATTEMPTS TO OBTAIN THIS INFO. AT THIS TIME, THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS PROVIDED IN THE ABSTRACT. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. EROSION A SLIPPAGE OF THE DEVICES ARE SURGICAL AND PHYSIOLOGICAL COMPLICATIONS AND AN ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING: THE MFR OF THE LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM HAS DESIGNED, TESTED AND MANUFACTURED IT TO BE REASONABLY FIT FOR ITS INTENDED USE. HOWEVER, THE LAP-BAND 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 SYSTEM MAY BE EASILY DAMAGED BY IMPROPER HANDLING OR USE. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF BAND SLIPPAGE AS FOLLOWS: "THERE IS A RISK OF BAND EROSION INTO STOMACH TISSUE. RE-OPERATION TO REMOVE THE DEVICE IS REQUIRED. CAUTION: AS WITH OTHER GASTROPLASTY SURGERIES, PARTICULAR CARE MUST BE TAKEN DURING DISSECTION AND DURING IMPLANTATION OF THE DEVICE TO AVOID DAMAGE TO THE GASTROINTESTINAL TRACT. ANY DAMAGE TO THE STOMACH DURING THE PROCEDURE MAY RESULT IN EROSION OF THE DEVICE INTO THE GI TRACT." 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."

    Description of Event or Problem · 1

    RECEIVED ABSTRACT PUBLISHED IN "OBES SURG (2012) 22:1315-1419" THROUGH FORWARDED PRODUCT/WATCH FROM ALLERGAN GLIS DEPARTMENT ABSTRACT: LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING. SUTURED BAND FIXATION VS. NON-SUTURED TECHNIQUE. CERNY, S. (REPRINT); SLADECEK, P. OBESITY SURGERY, (SEP 2012) VOL. 22, NO. 9, P. 1373. NO ADD'L INFO IS AVAILABLE AT THIS TIME. IT IS NOT CLEAR IF THE DEVICES ASSOCIATED WITH THE ABSTRACT ARE ALLERGAN DEVICES. THE DEVICES ARE NOT AVAILABLE TO ALLERGAN FOR PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention