LoFric® Origo™ 44312 (REF 4431240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07392532158292), received between Jan 8, 2018 and Jun 4, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE COMPLAINT REPORTER THE USER WAS INSTRUCTED ON THE (B)(6) ON HOW TO PERFORM INTERMITTENT CATHETERIZATION (IC). THE USER HAD THEN SELF CATHETERIZED AS USUAL. IN THE MORNING OF (B)(6) 2020 AND DURING INSERTION IN THE BLADDER, AS USER DESCRIBED, IT STARTED TO BLEED "RELATIVELY HEAVILY" WITH BLOOD CLOTS COMING OUT A BIT LATER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10117663 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT OCCURED IN (B)(6), I.E. OUTSIDE USA. ACCORDING TO COMPLAINT REPORTER, THE PATIENT BEGUN PERFORMING INTERMITTENT CATHETERIZATION THERAPY, AFTER TRAINING BY HEALTHCARE PROFESSIONAL ON (B)(6) 2020 AND WITHOUT PROBLEMS THE FIRST DAYS AT HOME. THE PATIENT, WHO IS CONCOMITANTLY TREATED WITH ANTICOAGULANT THERAPY, NOTICED A BLEEDING ((B)(6)) AND ON THE DAY AFTER HE ALSO NOTICED BLOOD LUMPS IN URINE. WHEN WITHDRAWING A CATHETER ON THE SAME DAY A MORE SEVERE BLEEDING DEVELOPED. THE PATIENT VISITED HIS UROLOGIST TO FOLLOWING DAY ((B)(6)). THE UROLOGIST INSERTED AN INDWELLING CATHETER AND URINARY COLLECTION BAG. THE BLEEDING DEVELOPED MORE SEVERELY OVER NIGHT AND THE USER WAS ADMITTED TO HOSPITAL ((B)(6)). THE BLEEDING STOPPED. PATIENT WAS TREATED WITH ANTIBIOTICS. SURGERY IS PLANNED FOR THE PATIENT, TO ENABLE BLADDER MANAGEMENT BY OTHER MEANS THAN INTERMITTENT CATHETERIZATION. THE PATIENT HAD REPORTED HE DID NOT SUSPECT ANY DEVICE DEFICIENCY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9828351 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED PAIN WHEN PERFORMING URINARY CATHETERISATION. AFTER A FEW DAYS THE PATIENT EXPERIENCED A BLEEDING WHEN PERFORMING URINARY CATHETERISATION AND WENT TO HOSPITAL. THE PATIENT WAS HOSPITALIZED FOR ONE DAY. THE BLEEDING DID NOT REOCCUR, AND THERE WERE NO OTHER MEDICAL COMPLICATIONS TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9278274 ↗
• InjuryJan 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THERE WAS NO WATER SACHET IN THE PACKAGE, AND THE PATIENT TRIED TO USE THE CATHETER ANYHOW. THE PATIENT CLAIMED HE WAS HURT AND EXPERIENCED BLEEDING, BUT RECOVERED WITHOUT SEQUELAE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7171128 ↗