BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC ORIGO

    MDR report key: 23776510 · Received December 11, 2025

    Report

    Report Number
    3009632672-2025-00042
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 11, 2025
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    EZD
    UDI-DI
    07333387043456
    PMA / PMN Number
    K250659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH DOCUMENTATION AND PRODUCTION DATA HAVE BEEN REVIEWED, AND NO DEVIATIONS OR EARLIER COMPLAINTS HAVE BEEN REGISTERED FOR THE LOT. NO DEVICE WAS RETURNED TO THE MANUFACTURER, SO IT WAS NOT POSSIBLE TO INCLUDE THE DEVICE USED IN THE INVESTIGATION. THE CAUSE OF THIS ADVERSE EVENT HAS NOT BEEN POSSIBLE TO ESTABLISH. 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

    THIS ADVERSE EVENT OCCURRED IN THE USA. A MALE PATIENT WITH THE MEDICAL CONDITION URINARY RETENTION, BPH, CONSTIPATION AND DIABETES, HAS BEEN USING A STERILE, SINGLE-USE, INTERMITTENT URINARY CATHETER, LOFRIC ORIGO COUDÉ (16'' 16FR). ON (B)(6) 2025, THE PATIENT INFORMED THE MANUFACTURER REPRESENTATIVE THAT HE HAD AN INCIDENT WITH THE CATHETER 2 DAYS AGO. THE PATIENT, WHO IS NEW TO THE THERAPY INTERMITTENT CATHETERIZATION, HAD PROBLEMS INSERTING THE CATHETER AND HE EXPERIENCED IT VERY RESISTANT TO INSERT. HE STATED HE DID EXPERIENCE PAIN WHEN HE MET THE RESISTANCE. AFTER HE HAD REMOVED THE CATHETER, SEVERE BLEEDING OCCURRED (PROBABLY A FRUIT JUICE GLASS SIZE OF BLOOD, ACCORDING TO THE PATIENT). THE PATIENT WENT TO THE HOSPITAL EMERGENCY DUE TO THE BLEEDING. HE STATED THAT THE HOSPITAL PLACED A FOLEY CATHETER AND TOLD HIM THAT HIS PROSTATE WAS SWOLLEN AND "PINCHED OFF THE URETHRA." HE WAS THEN RELEASED HOME. THE ONLY TREATMENT HE HAD WAS A FOLEY CATHETER INSERTED. HE STATED HE WILL HAVE THE FOLEY UNTIL ON (B)(6) AS THAT'S THE SOONEST THE UROLOGIST COULD SEE HIM. THE MANUFACTURER REPRESENTATIVE PROVIDED EDUCATION FOR IC TECHNIQUE, WAYS TO RELAX THE SPHINCTER AND EASE THE CATHETER IN, COUDE TIP AND INDICATOR RIDGE USE, AND ADVISED TO NEVER FORCE THE CATHETERS IN IF/WHEN HE RESUMES CIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553874 LOFRIC ORIGO CATHETER, STRAIGHT EZD WELLSPECT HEALTHCARE 44416 669839 07333387043456

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other