BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC DILACATH

    MDR report key: 3181413 · Received June 14, 2013

    Report

    Report Number
    3009632672-2013-00022
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    September 8, 2011
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    FBX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUBMISSION IS BEING MADE AFTER AN ACQUISITION AND INTERNAL AUDIT OF WELLSPECT HEALTHCARE. SAMPLES RETURNED HAVE BEEN ANALYZED AND NO DEFECTS OR DEVIATIONS COULD BE FOUND. BASED UPON THE PRODUCT TESTING, THIS COMPLAINT COULD NOT BE CONFIRMED AS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER THINKS THE COATING IS ROUGH AND HE HAD A BLEEDING AFTER CATHETERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270784 LOFRIC DILACATH URETHRAL DILATOR, FBX FBX WELLSPECT HEALTHCARE 40618 86793

    Patients

    Seq Age Sex Outcome Treatment
    1 Other