BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC

    MDR report key: 8054326 · Received November 9, 2018

    Report

    Report Number
    3009632672-2018-00004
    Event Type
    Injury
    Date Received
    November 9, 2018
    Report Date
    October 11, 2018
    Manufacturer
    WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB
    Product Code
    EZD
    UDI-DI
    07392532131721
    PMA / PMN Number
    K113424
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, WELLSPECT HEALTHCARE IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE USER EXPERIENCED A BLEEDING DURING URINE CATHETERIZATION. ALSO, THE MARK AT THE END OF THE CATHETER WAS OFF. NO MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894357 LOFRIC CATHETER, STRAIGHT EZD WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB 40516 07392532131721

    Patients

    Seq Age Sex Outcome Treatment
    1 Other