BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1841347 · Received September 13, 2010

    Report

    Report Number
    2024601-2010-00670
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS REC'D THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. CELLULITIS IS A SURGICAL AND PHYSIOLOGICAL COMPLICATION, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. NO ADD'L INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF CELLULITIS 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. CONTRAINDICATION(S): THE LAP-BAND SYSTEM IS CONTRAINDICATED IN: ...PTS WITH INFLAMMATORY DISEASES OF THE GASTROINTESTINAL TRACT, INCLUDING SEVERE INTRACTABLE ESOPHAGITIS, GASTRIC ULCERATION, DUODENAL ULCERATION, OR SPECIFIC INFLAMMATION SUCH AS CROHN'S DISEASE. THERE WERE ADD'L 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% SUBJECTS INCLUDED: INCISIONAL INFECTION, INFECTION, REDUNDANT SKIN, CONTACT DERMATITIS, ABNORMAL HEALING, EDEMA,...AND WOUND INFECTION."

    Description of Event or Problem · 1

    ALLERGAN REP REC'D A VOICEMAIL MESSAGE FROM A HEALTH PROFESSIONAL REQUESTING A RETURN KIT FOR AN EXPLANTED DEVICE TO BE ABLE TO RETURN THE PRODUCT TO ALLERGAN. NO ADD'L INFO WAS PROVIDED. F/U FINDINGS: PFN WAS REC'D BY ALLERGAN. EVENT DESCRIPTION STATES: "PORT EXPLANT DUE TO IMPROVED CELLULITIS AROUND THE PORT." THE DEVICE WAS RETURNED AND ANALYZED. THE SERIAL NUMBER OF THE DEVICE WAS NOT AVAILABLE FROM THE SURGEON. NO ADD'L INFO WAS PROVIDED BY THE RPTR OR THE SURGEON CONCERNING THE CELLULITIS AT THE PORT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention