BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 3001932 · Received March 11, 2013

    Report

    Report Number
    2024601-2013-00132
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    December 10, 2012
    Report Date
    February 13, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MED WATCH SENT TO FDA ON: (B)(4) 2013. 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 AND 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. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. 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

    HEALTHCARE PROFESSIONAL REPORTED A LAP-BAND PORT LEAK. THE LEAK WAS OBSERVED AFTER A "DISCREPANCY WITH AMOUNT OF FLUID WAS NOTED" AND A "CRACK IN TUBING" WAS NOTED. THE PORT WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101726 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR MULTIPLE VITAMINS| CONCERTA