BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ACCESS PORT KIT (UNK SIZE)

    MDR report key: 2140927 · Received June 21, 2011

    Report

    Report Number
    2024601-2011-00488
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2011. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF IRRITATION/INFLAMMATION AS FOLLOWS: "CONTRAINDICATION(S): THE LAP-BAND SYSTEM IS CONTRAINDICATED IN: PATIENTS WITH INFLAMMATORY DISEASES OF THE GASTROINTESTINAL TRACT, INCLUDING SEVERE INTRACTABLE ESOPHAGITIS, GASTRIC ULCERATION, DUODENAL ULCERATION, OR SPECIFIC INFLAMMATION SUCH AS CROHN'S DISEASE."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED SURGERY TO CORRECT THE PLACEMENT OF THE PORT DUE TO AN ALLEGED "EROSION OF THE LOW-PROFILE PORT JUST BENEATH THE SKIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ACCESS PORT KIT (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention