BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 3780701 · Received April 21, 2014

    Report

    Report Number
    2024601-2014-00202
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    November 8, 2011
    Report Date
    March 26, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT MODEL NUMBER, SERIAL NUMBER, DATE OF EVENT AND IMPLANT DATE. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO MODEL NUMBER, SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORT OF THE EVENT ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. BAND SLIPPAGE IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE MODEL NUMBER, SERIAL NUMBER, THE EVENT DATE, IMPLANT DATE, DIAGNOSTIC TESTING, PT DATA OR FURTHER EVENT DETAILS. SEE RELATED MEDWATCH REPORT # 2024601-2014-00203.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT THE LAP-BAND HAD SLIPPAGE AND REQUIRED TO BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241399 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention