LoFric® 40014 (REF 4001440)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07392532131844), received between May 9, 2018 and Jun 3, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2019Product Quality Problem; Manufacturing, Packaging or Shipping Problem; Product Quality Problem; Manufacturing, Packaging or Shipping Problem

  THE PATIENT EXPERIENCED PAIN DURING INTERMITTENT URINARY CATHETERIZATION (CIC). THE CATHETER WAS CAREFULLY REMOVED, AND THE PATIENT SAW THAT THE CATHETER TIP WAS CUT, WITH A SHARP ENDING. NO BLEEDING OCCURRED AND NO MEDICAL TREATMENT WAS REQUIRED. THE PAIN LASTED FOR THREE DAYS, AND THEN THE PATIENT HAD RECOVERED. NO MEDICAL COMPLICATION OCCURED. THIS EVENT OCCURRED IN (B)(6).

  Patient problems: Pain

  MAUDE report 8662387 ↗
• InjuryFeb 1, 2019Fracture; Fracture

  EVENT OCCURED IN (B)(6). ACCORDING TO THE REPORTER, THE NURSE NOTED THAT BLOOD CAME OUT WHEN THE NURSE REMOVED THE URINARY CATHETER FROM THE PATIENT AFTER BLADDER EMPTYING. AT THAT POINT, THE NURSE SAW THAT THE CATHETER END WAS SHARP AND THAT THERE WAS A PIECE OF THE CATHETER TIP MISSING. ACCORDING TO THE MANUFACTURER'S UNDERSTANDING, FROM THE DESCRIPTION PROVIDED BY THE REPORTER, THE MISSING PART, I.E. THE CATHETER TIP, WAS LEFT IN THE CATHETER PACKAGING AND NOT INSERTED INTO THE PATIENT. THE BLEEDING WAS SAID HAVING LASTED 6 HOURS AFTER CATHETERISATION, BUT DID NOT RE-OCCUR AFTER THAT. NO NEGATIVE OUTCOME HAS BEEN OBSERVED FOLLOWING THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8296047 ↗
• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, WHICH IS THE USER HIMSELF, HE FELT PAIN DURING URINARY CATHETERIZATION AND WHEN REMOVING THE CATHETER HE EXPERIENCED BLEEDING. AFTER REMOVING THE CATHETER, HE SAW A PIECE OF PLASTIC AT THE CATHETER EYE (HOLE). THE REPORTER EXPERIENCED PAIN AND ALSO OCCASIONAL BLEEDING SEVERAL TIMES WHEN INSERTING A URINARY CATHETER (UP TO SIX TIMES PER DAY), DURING A PERIOD OF ONE WEEK. THE REPORTER DID NOT VISIT ANY HOSPITAL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7497654 ↗