LoFric® Primo™ 41512Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07392532131615), received between May 27, 2020 and Oct 20, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Product Quality Problem” (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.

• InjuryOct 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED ANOTHER MODEL OF URINARY CATHETER THAN HE WAS PRESCRIBED (PATIENT RECEIVED A 40 CM CATHETER SIZE 12FR COUDE TIP, INSTEAD OF THE PRESCRIBED 40 CM CATHETER SIZE 16FR STRAIGHT TIP), DUE TO A MISTAKE WHEN THE PRODUCTS WERE DELIVERED FROM THE WAREHOUSE. THE LABELLING INFORMATION FOR THE DELIVERED PRODUCTS WAS CORRECT. THE PATIENT NOTICED THAT THE PACKAGE WAS DIFFERENT, BUT USED THE DELIVERED PRODUCTS ANYWAY AND EXPERIENCED A BLEEDING DURING THE URINARY CATHETERIZATION PROCEDURE. THE DAY AFTER, THE PATIENT HAD AN ALREADY SCHEDULED APPOINTMENT AT THE DOCTOR, AND AT THAT TIME THERE WAS NO BLEEDING. THE NEXT DAY THE BLEEDING RESUMED, AND THE PATIENT REVISITED THE DOCTOR. THE PATIENT RECEIVED A FOLEY CATHETER TO HAVE IN PLACE FOR AT LEAST TWO WEEKS. NO OTHER MEDICAL COMPLICATIONS ARE REPORTED, NO HOSPITALIZATION WAS NEEDED. THE PATIENT TAKES ANTICOAGULANT TREATMENT. THE OVERALL CONDITION FOR THE PATIENT WAS WELL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10703665 ↗
• InjuryMay 27, 2020Product Quality Problem; Product Quality Problem

  THE EVENT OCCURRED IN (B)(6), I.E. OUTSIDE USA. ACCORDING TO COMPLAINT REPORT THE PATIENT INJURED THE URETHRA AND EXPERIENCED A MINOR BLEEDING DURING THE CATHETERIZATION PROCEDURE. THE PATIENT, WHO IS SAID TO BE AN EXPERIENCED USER OF URINARY CATHETERS HAD DESCRIBED THAT THERE WAS A SMALL PLASTIC PART ON THE TIP OF THE CATHETER WHICH GOT STUCK IN THE URETHRA. THE PATIENT HAD SAID HE REMOVED THE SMALL PLASTIC PART BY "PUSHING AND PULLING ON IT", BY HIMSELF. A MINOR BLEEDING WAS NOTICED AND THE PATIENT MET A DOCTOR AND WAS GIVEN AN INDWELLING CATHETER WHILE HEALING. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED, AND IN GOOD HEALTH.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10090929 ↗