LoFric® 40012 (REF 4001240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07392532131851), received between Oct 31, 2018 and Jan 17, 2020 — classified as 3 injuries, 1 malfunction.

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 16, 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.

• InjuryJan 17, 2020Sharp Edges; Sharp Edges

  COMPLAINT INFORMATION PROVIDED BY USER LOCATED IN (B)(6) (REPORTER) IN WRITING AND VIA ORAL FOLLOW UP COMMUNICATION: THE REPORTER UNDERWENT A BLADDER AUGMENTATION (AUGMENTATION CYSTOPLASTY) IN YR2000 AND HAS USED THE MANUFACTURER'S CATHETERS FOR INTERMITTENT URINARY CATHETERIZATION (IC) SINCE THEN, 5-6 TIMES DAILY. HE CLAIMS HAVING EXPERIENCED PROBLEMS, WHEN PERFORMING THE IC-PROCEDURE, WITH THE CATHETERS' COATING AND REPEATEDLY DURING THE LAST 14 YRS BUT HAS NOT RAISED ANY COMPLAINT EARLIER. THE CATHETER COATING IS CLAIMED TO SOMETIMES BE ROUGH OR SHARP. THIS IS SAID TO HAVING CAUSED CONSIDERABLE DISCOMFORT, CAUSING BLEEDINGS THAT IN TURN IS HAS LED TO FREQUENT INFECTIONS WITH REPEATED ANTIBIOTIC TREATMENTS. THE PATIENTS HAS VISITED SEVERAL UROLOGISTS AND GPS, BUT THE HEALTHCARE PROFESSIONALS HAS NOT UNDERSTOOD WHY HE HAS HAD THESE INFECTIONS. THE REPORTER HAS HOWEVER RECENTLY CONCLUDED IT IS CAUSED BY THE CATHETERS WHICH IS WHY HE WAS NOW REPORTING THE MATTER. THE BATCH OF LOFRIC CATHETERS BEING USED AT THE TIME OF RAISING THE COMPLAINTS IS SAID NOT TO CAUSE ANY PROBLEMS LIKE THOSE DESCRIBED. HE WAS ENCOURAGED TO SEND THE MANUFACTURER LOT NUMBERS AND SAMPLES OF PREVIOUS BATCHES,

  Patient problems: Urinary Tract Infection

  MAUDE report 9599755 ↗
• MalfunctionJun 20, 2019Product Quality Problem; Product Quality Problem

  REPORTED FROM (B)(6). ACCORDING TO THE REPORTER (A PHARMACIST, WHO HAD RECEIVED INFORMATION FROM AN ORTHOPEDIC) A PATIENT USING A CATHETER EXPERIENCED IT BROKE DURING WITHDRAWAL. THE REMAINING PIECE WAS REMOVED IN HOSPITAL CARE.

  Patient problems: No Code Available

  MAUDE report 8715767 ↗
• InjuryMar 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO REPORTER: AFTER ABOUT 10 DAYS OF USE, DURING WETTING AND LUBRICATION OF CATHETER A DERMATITIS WAS SAID TO APPEAR ON THE THUMB AND FOREFINGER OF BOTH HANDS. NO DERMATOLOGICAL EXAMINATION WAS PERFORMED NOR HAS MEDICAL CARE BEEN SOUGHT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8389434 ↗
• InjuryOct 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE USER EXPERIENCED URINARY TRACT INFECTIONS (UTI) .

  Patient problems: Urinary Tract Infection

  MAUDE report 8022918 ↗