BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 1854238 · Received September 3, 2010

    Report

    Report Number
    2024601-2010-00642
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 12, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2010. 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. 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

    HEALTH PROFESSIONAL REPORTED "DURING TIMES OF ADJUSTMENT, IT WAS NOTED IN THE CLINIC THAT FLUID WAS MISSING FROM THE BAND." F/U FINDINGS: AN X-RAY WAS TAKEN, EXPLANTING DOCTOR COULDN'T SEE A LEAK, BUT FLUID WAS MISSING. THE PORT WAS REPLACED WITH A NEW PORT. THE PORT IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR GABAPENTIN| ARMOUR| CHROMATE| ESTRADIOL