BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 2871738 · Received December 11, 2012

    Report

    Report Number
    2024601-2012-01279
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 17, 2012
    Report Date
    November 20, 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). 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. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    PHYSICIAN REPORTS "REPLACEMENT OF FAILED LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM - HOLE IN BAND NEAR BUCKLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 2240217

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR