BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.6F PRO-FUSE CT LP ATT POLY

    MDR report key: 3001003 · Received February 27, 2013

    Report

    Report Number
    2518902-2013-00012
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MEDCOMP
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. WHEN THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING A ROUTINE FLUSH, SWELLING WAS NOTED IN THE SUBCUTANEOUS TISSUE AROUND THE PORT. A SMALL HOLE WAS DETECTED IN THE PORT BASE AFTER IT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83537 6.6F PRO-FUSE CT LP ATT POLY CT INFUSION PORT LJT MEDCOMP MRCTT66041-C UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention HUBER NEEDLE