BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2770342 · Received October 1, 2012

    Report

    Report Number
    2024601-2012-00893
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    May 22, 2012
    Report Date
    September 5, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. HEALTH PROFESSIONAL HAS DECLINED TO PROVIDE ADD'L INFO. DEVICE LABELING INSTRUCTS SURGEONS TO: "VIEW THE INFLATABLE PORTION OF THE BAND FOR LEAKS OR UNEVEN INFLATION." PRIOR TO PRODUCT PLACEMENT.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED, "BAND EXPLANTED DUE TO MALFUNCTION OF LAP BAND DUE TO ANEURYSM OF BALLOON. REPLACED WITH APS BAND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1747478

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention