BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC ORIGO

    MDR report key: 22335863 · Received June 26, 2025

    Report

    Report Number
    3009632672-2025-00017
    Event Type
    Injury
    Date Received
    June 26, 2025
    Date of Event
    June 12, 2025
    Report Date
    June 26, 2025
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    EZD
    UDI-DI
    07333387043319
    PMA / PMN Number
    K122078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH DOCUMENTATION AND PRODUCTION DATA HAVE BEEN REVIEWED AND NO RELEVANT PROBLEMS OR DEVIATIONS WERE REGISTERED. NO EARLIER COMPLAINTS REGISTERED FOR THIS LOT. THE USER HAS DISCARDED THE SHARP CATHETERS AND HE HAS NO MORE OF THE SAME LOT TO SEND BACK. HE WILL NOT DISCLOSE ANY MORE INFORMATION ABOUT HIS MEDICAL HISTORY, MEDICATION ETC AND DID NOT TAKE ANY PICTURES OF THE PRODUCTS. IT IS NOT POSSIBLY TO VERIFY THAT THE CATHETERS WHERE IN FACT SHARP AND CONTRIBUTED TO THE BLEEDING. WITH THIS LIMITED INFORMATION, AND WITH NO PRODUCTS RETURNED, AT THIS POINT IT IS NOT POSSIBLE TO ESTABLISH ANY ROOT CAUSE. 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 · 0

    ADVERSE EVENT OCCURRED OUTSIDE US, IN GREAT BRITAIN. MALE PATIENT REPORTED THAT 5-6 OF HIS CATHETERS RECENTLY FELT LIKE THEY HAD SHARP RIDGES ON THEM. AFTER USING ONE OF THE CATHETERS, HE DISINFECTED IT AND EXAMINED IT BY HAND. HE DESCRIBES THAT HE COULD FEEL LIKE A "CHISEL MARK". ON TWO OCCASIONS HE EXPERIENCED MINOR BLEEDING AFTER USING CATHETERS THAT HE PERCEIVED AS SHARP. HE DID NOT SEEK ANY MEDICAL ATTENTION AND HAS RECOVERED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491027 LOFRIC ORIGO CATHETER, STRAIGHT EZD WELLSPECT HEALTHCARE 44312 663600 07333387043319

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male