BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2971608 · Received January 30, 2013

    Report

    Report Number
    2024601-2013-00020
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    November 28, 2012
    Report Date
    January 4, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE). (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 EITHER A TAPER II OR RAPIDPORT EZ STRAIN RELIEF. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR MODEL NUMBER. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PROT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A LAP-BAND PORT LEAK FIRST NOTICED WHEN PHYSICIAN NOTED "MISSING FLUID" DURING AN ADJUSTMENT FILL. DURING EXPLANT SURGERY, PHYSICIAN NOTED A "BLUE RING AT THE BACK OF THE PORT" THAT CONFIRMED THE LEAK. THE PORT WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41744 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR