BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC CLASSIC

    MDR report key: 8022918 · Received October 31, 2018

    Report

    Report Number
    3009632672-2018-00005
    Event Type
    Injury
    Date Received
    October 31, 2018
    Report Date
    October 10, 2018
    Manufacturer
    WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB
    Product Code
    EZD
    UDI-DI
    07392532131851
    PMA / PMN Number
    K113424
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS NOT RECEIVED THE DEVICE LOT NUMBER, OR THE USED PRODUCT FOR INVESTIGATION. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING THE DEVICE, OR ANY LOT NUMBER INFORMATION, WELLSPECT HEALTHCARE IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR CAUSE OF 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 URINARY TRACT INFECTIONS (UTI) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866208 LOFRIC CLASSIC CATHETER, STRAIGHT EZD WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB 40012 07392532131851

    Patients

    Seq Age Sex Outcome Treatment
    1 Other