BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AP STANDARD RAPID-PORT EZ

    MDR report key: 1971620 · Received January 25, 2011

    Report

    Report Number
    2024601-2010-01081
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 11, 2010
    Report Date
    December 27, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RAPID PORT EZ STRAIN RELIEF. (B)(4). VISUAL EXAM OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A RAPIDPORT EZ STRAIN RELIEF. ANALYSIS NOTED THE ACCESS PORT HAD NON-PENETRATING NICKS WITH STRIATIONS DESCRIBED AS SURGICAL TOOL SCRATCH-LIKE. THE BAND TUBING WAS BROKEN WITH STRIATIONS CONSISTENT WITH A SURGICAL END CUT TO REMOVE THE DEVICE. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN INFECTION AS FOLLOWS: "INFECTION CAN OCCUR IN THE IMMEDIATE POST-OPERATIVE PERIOD OF YRS 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 A LAP-BAND THAT WAS REMOVED BECAUSE PT WAS "SEPTIC DUE TO AN INFECTION." THE DEVICE WAS REMOVED AND NOT REPLACED. THE HEALTH PROFESSIONAL IS UNSURE IF THE INFECTION IS DEVICE RELATED. THIS EVENT IS BEING REPORTED BECAUSE ALLERGAN'S APPROACH TO COMPLIANCE IS TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AP STANDARD RAPID-PORT EZ LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention PT IS CURRENTLY TAKING MULTIVITAMINS