BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITRACK 250A

    MDR report key: 4258667 · Received September 3, 2014

    Report

    Report Number
    3005641545-2014-00003
    Event Type
    Malfunction
    Date Received
    September 3, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 28, 2014
    Manufacturer
    ELLEX ISCIENCE, INC
    Product Code
    MPA
    PMA / PMN Number
    K080067
    Removal / Correction Number
    3005641545-08/11/14-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO DEVICES FROM SAME LOT WERE REMOVED FROM THE PACKAGING AND WERE FOUND TO BE MISSING A SEAL ON THE STERILE BARRIER POUCH AND THEREFORE WERE NOT STERILE. BOTH DEVICES WERE DETECTED AS NOT STERILE PRIOR TO USE AND WERE NOT USED FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535766 ITRACK 250A OPHTHALMIC MICROCATHETER, MPA, MHX MPA ELLEX ISCIENCE, INC ITRACK 1404-03

    Patients

    Seq Age Sex Outcome Treatment
    1 Other