BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ACCESS PORT KIT

    MDR report key: 1181233 · Received September 29, 2008

    Report

    Report Number
    2024601-2008-00750
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    July 2, 2007
    Report Date
    September 4, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER TYPE II. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. PAIN AND INFECTION ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN INFECTION AS FOLLOWS: INFECTION CAN OCCUR IN THE IMMEDIATE POST-OPERATIVE PERIOD OR YEARS AFTER INSERTION OF THE DEVICE. IN THE PRESENCE OF INFECTION OR CONTAMINATION, REMOVAL OF THE DEVICE IS INDICATED.

    Description of Event or Problem · 1

    REPORTED BY PATIENT AS: "I HAD A SECOND INFECTED PORT. I WAS TREATED WITH INTRAVENOUS ANTIBIOTICS, AND THE PORT WAS REMOVED. I SPEND A FEW DAYS IN THE HOSPITAL." FOLLOW UP WITH THE DOCTOR REVEALS: "3 ATTEMPTS AT DUE DILIGENCE TO ASK IF THIS INFECTION AND PAIN WERE DEVICE RELATED WITH NO REPLY BACK FROM THE PHYSICIAN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ACCESS PORT KIT DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R