BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 2192430 · Received July 26, 2011

    Report

    Report Number
    2024601-2011-00594
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    May 19, 2011
    Report Date
    July 5, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RPTR OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE RPTR, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. IRRITATION, INFECTION AND WOUND DRAINAGE ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE 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." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF IRRITATION AND EDEMA AS FOLLOWS: CAUTION: PTS MUST BE CAUTIONED TO CHEW THEIR FOOD THOROUGHLY. PTS WITH DENTURES MUST BE CAUTIONED TO BE PARTICULARLY CAREFUL TO CUT THEIR FOOD INTO SMALL PIECES. FAILURE TO FOLLOW THESE PRECAUTIONS MAY RESULT IN VOMITING, STOMAL IRRITATION AND EDEMA, POSSIBLY EVEN OBSTRUCTION. DEVICE LABELING ADDRESSES THE POTENTIAL OF ADVERSE EVENTS AS FOLLOWS: "CAUTION: IT IS THE RESPONSIBILITY OF THE SURGEON TO ADVISE THE PT OF THE KNOWN RISKS AND COMPLICATIONS ASSOCIATED WITH THE SURGICAL PROCEDURE AND IMPACT."

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED AS: TWO MONTHS AFTER IMPLANTATION A SMALL TENDER RED LUMP WAS NOTED TO THE LEFT OF THE PORT SITE INCISION, AND THE DOCTOR STARTED ANTIBIOTICS. A WEEK AND HALF LATER THE REDNESS AT THE INCISION SITE INCREASED, AND ANTIBIOTICS WERE REPEATED (KEFLEX, 500 MG, QID X 1 WEEK). TWO DAYS LATER THE SURGEON DRAINED AND PACKED THE SITE. THE DEVICE WAS REMOVED AND NO REPLACEMENT DEVICE WAS IMPLANTED. FOLLOW UP FINDINGS: THE PHYSICIAN IS UNSURE OF THE CAUSALITY OF THE PORT SITE INFECTION. PER THE PHYSICIAN THE CULTURE CAME BACK NEGATIVE. NO GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) LTI ALLERGAN NA 2075696

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention PREMARIN, 625MG