BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC ORIGO

    MDR report key: 10634329 · Received October 6, 2020

    Report

    Report Number
    3009632672-2020-00010
    Event Type
    Injury
    Date Received
    October 6, 2020
    Report Date
    October 6, 2020
    Manufacturer
    WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB
    Product Code
    EZD
    UDI-DI
    07392532122583
    PMA / PMN Number
    K122078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE PRODUCTION BATCH RECORDS DID NOT PROVIDE ANY CONCLUSION FOR ROOT CAUSE. NO EARLIER COMPLAINTS REGISTERED FOR THIS LOT. NO PRODUCTS OF THE ACTUAL BATCH HAVE BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. 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 ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OF CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE PATIENT, IT WAS DIFFICULT TO INSERT AND TO REMOVE THE URINARY CATHETER, AND HE EXPERIENCED A BLEEDING WHEN THE CATHETER WAS REMOVED. THE PATIENT WAS UNSURE IF THE CATHETER WAS ENOUGH LUBRICATED. THE NEXT DAY, THE PATIENT HAD AN ALREADY SCHEDULED APPOINTMENT TO A UROLOGY DOCTOR, AND AT THAT TIME HE EXPERIENCED A MINOR BLEEDING. 36 HOURS LATER, THE PATIENT EXPERIENCED FEVER AND WENT TO THE HOSPITAL, WHERE HE WAS DIAGNOSED WITH A URINARY TRACT INFECTION (UTI) AND RECEIVED ANTIBIOTICS. THE PATIENT REPORTED THAT HE HAD A STENT (PLACED IN URETER/URETHTRA) REMOVAL TWO WEEKS BEFORE THIS INCIDENT, AND HE WAS THEN ALSO TREATED FOR A UTI. IT WAS NOT ESTABLISHED IF THE NEW UTI WAS RECURRENT FROM THE PREVIOUS UTI AND THE STENT REMOVAL, OR RELATED TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102611 LOFRIC ORIGO CATHETER STRAIGHT EZD WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB 44416 442691 07392532122583

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other