BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOFRIC PRIMO

    MDR report key: 24647485 · Received March 20, 2026

    Report

    Report Number
    3009632672-2026-00010
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 20, 2026
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    EZD
    UDI-DI
    07333387043012
    PMA / PMN Number
    K122078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS TRIED TO GET MORE INFORMATION ABOUT THE DAMAGED PRODUCTS AND RECEIVED THE ANSWER FROM THE PATIENT THAT THE PRODUCTS HAD BEEN DISCARDED AND NO PHOTOS WERE AVAILABLE. THE PATIENT SENT A PHOTO OF THE SECONDARY PACKAGE. THE MANUFACTURER DISCOVERED THAT THE SECONDARY PACKAGE HAD BEEN RELABELED BY A PARALLEL IMPORTER. THE CONCERNED LOT 670418 FOR THIS ADVERSE EVENT IS CONNECTED TO REFERENCE NUMBER 4101430. THE PARALLEL IMPORTER HAD OVER-LABELED THE CORRECT REFERENCE NUMBER 4101430 WITH THE INCORRECT REFERENCE NUMBER 4101425. REFERENCE NUMBER 4101430 AND 4101425 ARE THE SAME MODEL (41014) BUT THE TWO LAST DIGITS ARE DIFFERENT DEPENDING ON INTENDED MARKET WHERE 30 IS FOR ITALY AND 25 IS FOR UNITED KINGDOM. BATCH DOCUMENTATION AND PRODUCTION DATA HAVE BEEN REVIEWED, AND NO RELEVANT PROBLEMS OR DEVIATIONS WERE REGISTERED. NO EARLIER COMPLAINTS ARE REGISTERED FOR THIS LOT. EXAMINATION OF PRODUCT SAMPLES COULD NOT BE CARRIED OUT SINCE NONE WERE RETURNED. DUE TO LIMITED INFORMATION ABOUT THE DAMAGED PRODUCTS, IT IS NOT POSSIBLE TO INVESTIGATE THIS ADVERSE EVEN FURTHER. WITHOUT PRODUCT SAMPLES AND/OR PICTURES THE ROOT CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE ADVERSE EVENT OCCURRED OUTSIDE US, IN GREAT BRITAIN. ON (B)(6) 2026, A MALE PATIENT CONTACTED THE MANUFACTURER REPRESENTATIVE AND REPORTED THAT THE PRIMARY PACKAGE OF THE SINGLE-USE INTERMITTENT URINARY CATHETER LOFRIC PRIMO (40CM, CH14) WAS DAMAGED. WHEN THE WATER SACHET INSIDE THE PRIMARY PACKAGE WAS SQUEEZED, THE WATER PARTIALLY ESCAPED THROUGH A HOLE IN THE PRIMARY PACKAGE. SINCE THE PRIMARY PACKAGE IS THE STERILE BARRIER OF THE PRODUCT, A HOLE IN THE PRIMARY PACKAGE IS COMPROMISING THE STERILE BARRIER OF THE PRODUCT. THE PATIENT REPORTED THAT HE HAD RECEIVED THREE DAMAGED PRODUCTS AND THAT HE HAD DISCARDED THESE THREE PRODUCTS WITHOUT USING THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15513 LOFRIC PRIMO LOFRIC PRIMO NELATON MALE 40CM CH14 EZD WELLSPECT HEALTHCARE 41014 670418 07333387043012

    Patients

    Seq Age Sex Outcome Treatment
    1