BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND SYSTEM ACCESS PORT II KIT

    MDR report key: 3113699 · Received May 10, 2013

    Report

    Report Number
    2024601-2013-00341
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    February 20, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P00008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: 05/10/2013. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AS THE DEVICE WAS NOT EXPLANTED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. INFECTION, PAIN, ABCESS 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: "CONTRAINDICATIONS THE LAP-BAND SYSTEM IS CONTRAINDICATED IN: PTS WHO HAVE AN INFECTION ANYWHERE IN THEIR BODY OR WHERE THE POSSIBILITY OF CONTAMINATION PRIOR TO OR DURING THE SURGERY EXISTS." "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 INFECTION, PAIN, ABCESS AND WOUND DRAINAGE AS FOLLOWS: "THERE WERE ADDITIONAL OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE RELATED TO THE LAP-BANDS SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ESOPHAGITIS, GASTRITIS, HIATAL HERNIA, PANCREATITIS, ABDOMINAL PAIN, HERNIA, INCISIONAL INFECTION, INFECTION, REDUNDANT SKIN, DEHYDRATION, GI PERFORATION, DIARRHEA, ABNORMAL STOOLS, CONSTIPATION, FLATULENCE, DYSPEPSIA, ERUCTATION, CARDIOSPASM, HEMATEMESIS, ASTHENIA, FEVER, CHEST PAIN, INCISION PAIN, CONTACT DERMATITIS, ABNORMAL HEALING, EDEMA, PARESTHESIA, DYSMENORRHEA HYPOCHROMIC ANEMIA, BAND LEAK, CHOLECYSTITIS, ESOPHAGEAL DYSMOTILITY, ESOPHAGEAL ULCER, ESOPHAGITIS, PORT DIS-PLACEMENT, PORT SITE PAIN, SPLEEN INJURY, AND WOUND INFECTION."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A LAP-BAND ACCESS PORT INFECTION. THE EVENT WAS FIRST NOTICED WHEN THE "PATIENT CAME FOR F/U [FOLLOW UP] C/O [COMPLAINT OF] PAIN AT PORT SITE. PT [PATIENT] CAME IN [FIVE DAYS LATER] EXPERIENCING DRAINAGE FROM INFECTION." THE PATIENT WAS "PUT ON BACTRIM." THE PORT REMAINS IMPLANTED. THE PATIENT REPORTED THEY "DEVELOPED A SEROMA." PATIENT STATED THAT "THE DOCTOR TOLD ME TO CLEAN IT WITH A LARGE Q TIP AND PACK IT WITH LODOFORM." HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT DID NOT DEVELOP A SEROMA AND THAT PATIENT HAD AN "INFECTION/ABSCESS." HEALTHCARE PROFESSIONAL REPORTED THAT THE "DOCTOR CLEANS THE OPEN WOUND W/H202 AND PACKS W/RIBBON GAUZE AND DRESSES. FOLLOWS UP EVERY WEEK AND HAS THE PATIENT CLEAN AND REPACK EVERY DAY UNTIL THE WOUND HEALS FROM THE INSIDE OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207448 LAP-BAND SYSTEM ACCESS PORT II KIT LTI ALLERGAN NA 2139785

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention "KETOCONAZOLE CREAM 2% PM"| "AMITRIPTYLINE 25MG"| "LISINOPRIL 20 MG TAB QD"