BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AP STANDARD RAPID-PORT EZ

    MDR report key: 4071875 · Received August 12, 2014

    Report

    Report Number
    2024601-2014-00426
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    March 25, 2014
    Report Date
    July 23, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS RECEIVED THE PRODUCT HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. PAIN, NAUSEA, AND VOMITING ARE SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A LAP-BAND WITH A LEAK, FOR WHICH THE PATIENT WAS EXPERIENCING "EPIGASTRIC PAIN, NAUSEA AND VOMITING, AND COULD NOT KEEP ANYTHING DOWN." THE EVENTS WERE FIRST NOTICED WHEN THE PATIENT CAME TO THE EMERGENCY ROOM WITH "EPIGASTRIC PAIN." THE LAP-BAND SYSTEM WAS REMOVED, BUT THE DEVICE WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478949 AP STANDARD RAPID-PORT EZ LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR