BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2862109 · Received November 29, 2012

    Report

    Report Number
    2024601-2012-01259
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. MULTIPLE REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FORM THE REPORTER. "THE LAP-BAND SYSTEM SI NOT A LIFETIME PRODUCT AND IT MAY BREAK OR FAIL IN WHOLE OR IN PART AT ANY TIME AFTER IMPLANTATION AND NOTWITHSTANDING THE ABSENCE OF ANY DEFECT."

    Description of Event or Problem · 1

    ALLERGAN RECEIVED AN "EXPLANTED DEFECTIVE LAP-BAND." NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR