BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2844373 · Received November 5, 2012

    Report

    Report Number
    2024601-2012-01147
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS IF IT IS EXPLANTED IN THE FUTURE. THE DEVICE WAS REBUCKLED AND REMAINS IMPLANTED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT IF THE DEVICE IS RETURNED IN THE FUTURE. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, IF IT IS EXPLANTED IN THE FUTURE. IT WAS REBUCKLED DURING THE PROCEDURE AND ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE MODEL NUMBER, SERIAL NUMBER, THE SURGERY DATE, DIAGNOSTIC TESTING, PATIENT DATA OR FURTHER EVENT DETAILS. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN UNBUCKLED BAND AS FOLLOWS: WARNING: "FAILURE TO SECURE THE BAND PROPERLY MAY RESULT IN IT SUBSEQUENT DISPLACEMENT AND NECESSITATE RE-OPERATION." CAUTION: "FAILURE TO USE AN APPROPRIATE ATRAUMATIC INSTRUMENT SUCH AS THE LAP-BAND SYSTEM CLOSURE TOOL TO LOCK THE BAND MAY RESULT IN DAMAGE TO THE BAND OR INJURY TO SURROUNDING TISSUES."

    Description of Event or Problem · 1

    SURGEON REPORTED: "LAP-BAND SYSTEM UNBUCKLED. NO EXPLANT, JUST CLOSED BAND."

    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