LoFric® Origo™ 44416 (REF 4441640)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07392532122583), received between Oct 6, 2020 and Feb 21, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Product Quality Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT USED A LOFRIC ORIGO INTERMITTENT CATHETER FR16 WITH COUDE TIP ON (B)(6) 2023. THE PATIENT FELT A "SNAG" AND HAD SOME DIFFICULTY WITH INSERTION. THE FOLLOWING DAY ( (B)(6)2023) HE HAD A LARGE AMOUNT OF BLOOD AND BLOOD CLOTS IN HIS URINE. THIS CONTINUED A FEW DAYS. ON DAY 3 HE WENT TO HIS CARE CLINIC, BUT HIS URINE WAS CLEARED UP BY THEN. ONE ( (B)(6) 2023) HE SAW A SMALL AMOUNT OF BLOOD AGAIN, SO HE CALLED THE CARE CLINIC FOR EXAMINATION. HIS DOCTOR COULDN'T SAY IF HIS BLEEDING WAS RELATED TO HIS CATHETER USE OR NOT. THIS PATIENT DOES HAVE A HYDROCELE AND HERNIA AND WILL HAVE SURGERY IN (B)(6) 2023. THIS IS UNRELATED TO CATHETER USE. FURTHERMORE, THE PATIENT HAS HISTORY OF ENLARGE PROSTATE, HEART DISEASE AND TAKE A BLOOD THINNER MEDICINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16407270 ↗
• InjuryOct 6, 2020Product Quality Problem; Product Quality Problem

  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.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Urinary Tract Infection

  MAUDE report 10634329 ↗