BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2894217 · Received December 27, 2012

    Report

    Report Number
    2024601-2012-01338
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    March 22, 2010
    Report Date
    December 5, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. INTOLERANCE AND HEMATOMA 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 CONTRAINDICATION FOR PATIENTS REGARDING INTOLERANCE AS FOLLOWS: "PATIENTS WHO ARE KNOWN TO HAVE, OR SUSPECTED TO HAVE, AN ALLERGIC REACTION TO MATERIALS CONTAINED IN THE SYSTEM OR WHO HAVE EXHIBITED PAIN INTOLERANCE TO IMPLANTED DEVICES." "IT IS IMPORTANT TO DISCUSS ALL POSSIBLE COMPLICATIONS AND ADVERSE EVENTS WITH YOUR PATIENT. COMPLICATIONS WHICH MAY RESULT FROM THE USE OF THIS PRODUCT INCLUDE THE RISKS ASSOCIATED WITH THE MEDICATIONS AND METHODS UTILIZED IN THE SURGICAL PROCEDURE, THE RISKS ASSOCIATED WITH ANY SURGICAL PROCEDURE AND THE PATIENT'S DEGREE OF INTOLERANCE TO ANY FOREIGN OBJECT IMPLANTED IN THE BODY." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF HEMATOMA AS FOLLOWS: "SPECIFIC COMPLICATIONS OF LAPAROSCOPIC SURGERY CAN INCLUDE SPLEEN DAMAGE (SOMETIMES REQUIRING SPLENECTOMY) OR LIVER DAMAGE, BLEEDING FROM MAJOR BLOOD VESSEL, LUNG PROBLEMS, THROMBOSIS, AND RUPTURE OF THE WOUND."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED A LAP-BAND SYSTEM EXPLANT DUE TO INTOLERANCE. IT WAS ALSO REPORTED THAT THE PATIENT HAD AN "ER [EMERGENCY ROOM] VISIT S/P [STATUS POST]... FOR SMALL HEMATOMA AT PORT SITE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1702547

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R