LoFric® Sense™ 4161425Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07392532086489), received between Jun 4, 2019 and Aug 8, 2023 — classified as 2 injuries.

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.

• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 A FEMALE PATIENT WITH SJOGREN'S SYNDROME (AUTOIMMUNE DISORDER), GOT AN INTERMITTENT NELATON STRAIGHT TIP CATHETER (LOFRIC SENSE FR14) STUCK IN HER URETHRA DURING WITHDRAWAL. SHE HAD THEN TO GO TO EMERGENCY CARE FOR REMOVAL. THE CATHETER WAS REMOVED IN AN ER AND A PIECE OF MUCOSAL TISSUE WAS STUCK IN AN EYELET UPON REMOVAL. THE FEMALE PATIENT HAD BLEEDING AND A HEMATOMA DUE TO THE INJURY. THE PATIENT CAREGIVER (MOTHER) NOTED THE LOFRIC SENSE SOLUTION FELT THICK AND STICKY. THE ER DOCTOR BELIEVES DIAGNOSIS OF SJOGREN'S MAY BE AN INFLUENTIAL FACTOR AS PATIENTS EXPERIENCE DRYNESS IN MUCOSAL TISSUES. WITHIN THE WEEK PRIOR TO THEIR NEXT ER VISIT, PATIENT UROLOGIST PRESCRIBED MACROBID FOR A POSSIBLE UTI. THE ER PROVIDER PRESCRIBED AN ADDITIONAL 10 DAYS OF ANTIBIOTICS AFTER REMOVING THE LOFRIC SENSE CATHETER. THE ER ADVISED TO USE ADDITIONAL GEL LUBRICANT WITH LOFRIC SENSE GOING FORWARD. THE PATIENT CAREGIVER USED THIS TECHNIQUE FOR THE WEEK FOLLOWING THEIR ER VISIT, DIDN'T HAVE ANY ISSUES WITH LOFRIC SENSE, AND THEN RECEIVED ANOTHER CATHETER SAMPLES (CURE CATHETERS (INADVERTENTLY)), BUT THEY WORKED WELL FOR THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17478853 ↗
• InjuryJun 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE WAS REPORTED IN (B)(6). THE COMPLAINT WAS SUBMITTED BY THE CUSTOMER HERSELF. SHE HAD A SUPRAPUBIC CATHETER IN THE PAST. HER DOCTOR TOLD HER ON HER VISIT THAT SHE HAD "ABRASIONS" IN THE BLADDER AND SHE MAY NEED TO GET ANOTHER SUPRAPUBIC CATHETER TO HELP HEAL THE ABRASIONS IN THE BLADDER. THE UROLOGIST ADVISED HER TO CONTACT THE MANUFACTURER SALES REPRESENTATIVE TO CHECK IF THE CATHETERIZATION WITH LOFRIC SENSE HAS BEEN DONE CORRECTLY. THE GENERAL CONDITION OF THE PATIENT IS GOOD. THE CUSTOMER HAS NOT MENTIONED ANY UTI OR OTHER MEDICAL TREATMENTS OR HOSPITALIZATION. SHE INTENDS TO GO TO THE UROLOGIST AGAIN WITHIN THE NEXT 14 DAYS.

  Patient problems: No Information

  MAUDE report 8666416 ↗