BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    MDR report key: 1081566 · Received July 25, 2008

    Report

    Report Number
    2024601-2008-00390
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 22, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BIOENTERICS CORP.
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER I. MEDWATCH SENT TO FDA ON: 07/25/08. ALLERGAN HAS REC'D THE PRODUCT, HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER I. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. 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

    REPORTED AS: PORT RUPTURE (LEAK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM DEVICE FOR TREATMENT OF MORBID OBESITY LTI BIOENTERICS CORP. NA S00LB141

    Patients

    Seq Age Sex Outcome Treatment
    1