BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    MDR report key: 3243118 · Received July 18, 2013

    Report

    Report Number
    2024601-2013-00611
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4) 2013. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER I. ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. 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 DESCRIBES A LEAKING PORT TUBING AT THE STAINLESS STEEL CONNECTOR ON THE LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM. THE PORT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335569 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM LTI ALLERGAN NA S99LB520

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR