BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    MDR report key: 2800980 · Received October 18, 2012

    Report

    Report Number
    2024601-2012-01110
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    July 19, 2012
    Report Date
    September 21, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    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 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. INTOLERANCE IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. HEALTH PROFESSIONAL HAS DECLINED TO PROVIDE ADD'L INFO.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED: "BAND [AND] PORT EXPLANTED. PT DID NOT TOLERATE BAND TIGHTENINGS. PT DECIDED TO HAVE A SLEEVE GASTRECTOMY DONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG LTI ALLERGAN NA 1224217

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other