LoFric® Origo™ 44314 (REF 4431440)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07392532158308), received between Mar 9, 2020 and Sep 2, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE PATIENT, EVER SINCE THE MANUFACTURER CHANGED THE LAYOUT OF LOFRIC ORIGO DELIVERY BOX KNOWN AS CUSTOMER PACKAGE FROM DARK BLUE TO LIGHT BLUE, THE AMOUNT OF SALINE SOLUTION HAS BEEN INCONSISTENT. THE USER STATES WHEN HE REMOVES THE ACTIVATED LOFRIC ORIGO URINARY CATHETER OUT OF THE PACKAGE, SOMETIMES IT DRIPS AND OTHER TIMES IT DOESN'T- SUGGESTING THIS IS ONE INDICATION THE SOLUTION AMOUNT VARIES. THE PATIENT EXPLAINS HE CAN DISTINGUISH THE CATHETERS THAT AREN'T SUFFICIENTLY LUBRICATED ONLY ON CATHETERIZATION AS THEY CANNOT BE INSERTED SMOOTHLY, AND THE CATHETERIZATION IS UNCOMFORTABLE. ON (B)(6) 2021 THE PATIENT HAD A TRAUMATIC CATHETERIZATION WHICH RESULTED IN AN URGENT VISIT TO HIS UROLOGIST. HE HAD MODERATE TO LARGE BLEEDING WITH BLOOD CLOTS. THE UROLOGIST IRRIGATED THE PATIENT'S BLADDER, PLACED AND INDWELLING AND PRESCRIBED 10 DAYS OF CIPRO/ANTIBIOTIC. ON (B)(6) 2021 THE PATIENT HAD HIS FOLEY CATHETER REMOVED AND RESUMING IC USING THE LOFRIC ORIGO SUPPLY PER HIS UROLOGIST'S SUGGESTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 12413329 ↗
• InjuryMar 9, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE PATIENT HAS EXPERIENCED ALLERGIC REACTIONS (REDNESS, INFLAMMATION) WHEN USING THE URINARY CATHETER LOFRIC ORIGO. THE PATIENT HAS USED CATHETERS FOR AROUND 15 YEARS, THE ALLERGIC REACTIONS OCCURRED IN (B)(6) 2020. THE ALLERGIC REACTION WAS LOCALIZED ON THE GENITALS, NO OTHER PART OF THE BODY WAS AFFECTED. THE PATIENT USES THE SAME WIPES AND SOAP PRODUCTS AS BEFORE THE ALLERGIC REACTIONS OCCURRED. THERE WERE NO OTHER MEDICAL COMPLICATIONS. THE DOCTOR PRESCRIBED MEDICATION, AND THE PATIENT HAS RECOVERED. THE INCIDENT OCCURRED IN (B)(6).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9804517 ↗