BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2013265 · Received March 8, 2011

    Report

    Report Number
    2024601-2011-00196
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    September 15, 2009
    Report Date
    February 8, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED FOR ANALYSIS. BASED UPON THE IMPLANT DATE RANGE OF (B)(6) 2000 TO (B)(6) 2008, PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS EITHER A TAPER 1 OR TAPER II. SURGERY RELATED OBSERVATION/COMPLICATION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF SURGERY RELATED COMPLICATION/OBSERVATIONS AS FOLLOWS: "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 PT'S DEGREE OF INTOLERANCE TO ANY FOREIGN OBJECT IMPLANTED IN THE BODY." "CAUTION: IT IS THE RESPONSIBILITY OF THE SURGEON TO ADVISE THE PT OF THE KNOWN RISKS AND COMPLICATION ASSOCIATED WITH THE SURGICAL PROCEDURE AND IMPLANT."

    Description of Event or Problem · 1

    DOCTOR REPORTED EVENTS OF "SURGICAL-SITE PROBLEM" FORM JOURNAL ARTICLE, "THE EFFECTIVENESS OF ADJUSTABLE GASTRIC BANDING: A RETROSPECTIVE 6-YEAR U.S FOLLOW-UP STUDY", SURG ENDOSC (2011) 25:397-403. THIS MEDWATCH REPRESENTS THE 8 PTS LISTED IN TABLE 4 OF THE ARTICLE WHO WERE DIAGNOSED WITH SURGICAL-SITE PROBLEM.

    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