BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC TIEMANN CH16

    MDR report key: 3122469 · Received May 8, 2013

    Report

    Report Number
    3009632672-2013-00003
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 12, 2013
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    KOD
    PMA / PMN Number
    K896750
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES RETURNED HAVE BEEN ANALYZED AND SHOW NO DEFECTS OR DEVIATIONS. BATCH DOCUMENTATION HAS ALSO BEEN ANALYZED AND REVEALS NO DEVIATIONS. BASED UPON THE PRODUCT TESTING, THIS COMPLAINT COULD NOT BE CONFIRMED AS REPORTED.

    Description of Event or Problem · 1

    AFTER A CATHETERIZATION, THE USER HAD BLEEDING FROM THE URETHRA. THE FOLLOWING CATHETER WAS DIFFICULT TO INSERT DUE TO THE PREVIOUS BLEEDING, SO THE CUSTOMER WENT TO THE HOSPITAL TO GET ASSISTANCE. THE CUSTOMER HAD HIS BLADDER EMPTIED AT THE HOSPITAL. THE BLEEDING LASTED FOR ABOUT ONE DAY. HE HAS CONTINUED USING LOFRIC AND HAS NOT HAD ANY PROBLEMS SINCE THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200135 LOFRIC TIEMANN CH16 CATHETER, UROLOGICAL (KOD) KOD WELLSPECT HEALTHCARE 961600 125309

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R