BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3973030 · Received April 29, 2014

    Report

    Report Number
    2024601-2014-00216
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 2, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: 11/29/2014. ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS HAS NOT 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

    A HEALTHCARE PROFESSIONAL REPORTED A "MALFUNCTIONING LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)." THE REPORTER CLARIFIED "THE PORT WAS BROKEN AWAY FROM THE LAP-BAND AND WAS NOT STAYING FULL." THE LAP-BAND SYSTEM WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255580 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1782252

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR