BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AP STD, ACCESS PORT KIT RAPIDPORT EZ

    MDR report key: 3221847 · Received July 9, 2013

    Report

    Report Number
    2024601-2013-00573
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RAPIDPORT EZ STRAIN RELIEF. MEDWATCH SENT TO FDA ON: (B)(4) 2013. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE CATALOG NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A RAPIDPORT EZ STRAIN RELIEF. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: 'DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED AN ACCESS PORT "HAD CRACKED" AND SEPARATED FROM THE TUBING, SO IT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312467 AP STD, ACCESS PORT KIT RAPIDPORT EZ LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR