BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3111402 · Received May 7, 2013

    Report

    Report Number
    2024601-2013-00386
    Event Type
    Injury
    Date Received
    May 7, 2013
    Date of Event
    September 2, 2011
    Report Date
    April 8, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: 05/07/2013. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. PORT SITE PAIN AND INFECTION 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 REPORTED EVENT OF PORT SITE PAIN AS FOLLOWS: "THERE WERE ADDITIONAL OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ABDOMINAL PAIN, CHEST PAIN, INCISION PAIN AND PORT SITE PAIN." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF 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

    HEALTH PROFESSIONAL REPORTED PT IN (B)(4) STUDY EXPERIENCED "STATES SHE WAS HIT C/ A SOCCER BALL AROUND PORT AREA IN (B)(6) 2011. PT STATES SHE BRUISED APPROX ONE TO TWO INCHES ABOVE PORT AREA AND A QUARTER SIZE IN DIAMETER. PT STATES PORT REMAINED TENDER AND ON (B)(6) 2011, PT WAS PICKING UP A CHILD WHOSE FOOT HIT PORT AREA AND CAUSE A 'PINHOLE' OPENING AT PORT SITE. ON (B)(6) 2011, PORT WAS REMOVED. PORT WAS CLINICALLY INFECTED BUT CULTURE SHOWED NO GROWTH." BAND REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200095 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1569275

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention