BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2925011 · Received January 17, 2013

    Report

    Report Number
    2024601-2013-00014
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    April 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. MULTIPLE REQUESTS FOR FURTHER INFO HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FROM THE AUTHORS. EROSION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF EROSION AS FOLLOWS: CAUTION - THE BAND SHOULD NOT BE SUTURED TO THE STOMACH. SUTURING THE BAND DIRECTLY TO THE STOMACH MAY RESULT IN EROSION. 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. CAUTION - OVER-DISSECTION OF THE STOMACH DURING PLACEMENT MAY RESULT IN SLIPPAGE OR EROSION OF THE BAND AND REQUIRE REOPERATION. CAUTION - ANTI-INFLAMMATORY AGENTS, WHICH MAY IRRITATE THE STOMACH, SUCH AS ASPIRIN AND NON-STEROIDAL ANTI-INFLAMMATORY DRUGS, SHOULD BE USED WITH CAUTION. THE USE OF SUCH MEDICATIONS MAY BE ASSOCIATED WITH AN INCREASED RISK OF EROSION.

    Description of Event or Problem · 1

    REPORTED EVENTS OF POUCH DILATATION, BAND SLIPPAGE, "FLUID LEAK FROM BAND", OBSTRUCTION, "BAND MALFUNCTION", INFECTION, EROSION, ESOPHAGEAL DILATATION FROM JOURNAL ARTICLE: "OUTCOMES OF REVISION LAPAROSCOPIC GASTRIC BANDING: A RETROSPECTIVE STUDY, ANZJSURG.COM (2012). ALTHOUGH THE MFR OF THE DEVICE IS UNK, IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING. THIS MEDWATCH REPRESENTS THE 1 PT, LISTED IN TABLE 3 OF THE ARTICLE, WHO EXPERIENCED EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25725 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention