BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC ORIGO

    MDR report key: 10300538 · Received July 21, 2020

    Report

    Report Number
    3009632672-2020-00007
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    June 25, 2020
    Report Date
    July 21, 2020
    Manufacturer
    WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB
    Product Code
    EZD
    UDI-DI
    07392532122576
    PMA / PMN Number
    K122078
    Removal / Correction Number
    Z-2645-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL ATTEMPTS TO GET MORE INFORMATION ABOUT THE EVENT HAS BEEN MADE BUT WITHOUT SUCCESS AND IS HAS BEEN JUDGED IMPOSSIBLE TO GET MORE INFORMATION. EVEN THOUGH THE USED PRODUCT WAS NOT AVAILABLE FOR RETURN, AND RECALLED PRODUCTS SAMPLES FROM SAME LOT HAS NOT BEEN POSSIBLE TO ANALYSE IT CANNOT BE EXCLUDED THE EVENT WAS CAUSED BY THE PRODUCT QUALITY PROBLEM BEHIND THE ONGOING RECALL (Z-2645-2020).

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT, AFTER USE OF THE CATHETER THERE WAS A URETHRAL BLEEDING, AND THE USER WENT TO THE HOSPITAL. INFORMATION OF THE EXTENT OF BLEEDING, IF ONLY MINOR OR MORE SEVERE , OR IF PATIENT WAS HOSPITALISED OR ONLY VISITED A CLINIC FOR ADVICE OR TREATMENT HAS NOT BEEN POSSIBLE TO GET INFORMATION ABOUT ALTHOUGH SEVERAL ATTEMPTS HAS BEEN MADE TO GET INFORMATION. THIS INCIDENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768242 LOFRIC ORIGO LOFRIC ORIGO TIEMANN CH14, 40CM EZD WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB 44414 447036 07392532122576

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization