Onli 82144-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00610075056262), received between Oct 4, 2022 and Oct 4, 2022 — 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. How this data works · Data updated Oct 13, 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 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN END USER WHO USES INTERMITTENT CATHETERS DEVELOPED A UTI WHILE USING THE HOLLISTER ONLI INTERMITTENT URINARY CATHETER. THE END USER REPORTED THAT HE HAS A SPINAL CORD INJURY AND HAS NO SENSATION. HE SAID HE WAS EXPERIENCING DIFFICULTIES INSERTING THE CATHETERS AND FELT RESISTANCE DURING INSERTION. HE SAID HE DEVELOPED URINARY LEAKAGE, WHICH IS HIS TYPICAL SYMPTOM OF A UTI. HE SAID HIS DOCTOR DIAGNOSED HIM WITH A UTI AND SAID THE CATHETERIZATION PROCESS PROBABLY CAUSED INFLAMMATION LEADING TO THE UTI. HE STATED THE DOCTOR PLACED HIM ON ANTIBIOTICS AND THE END USER IS NOW FEELING FINE. THE END USER STATED HE NORMALLY EXPERIENCES 3 UTIS A YEAR.

  Patient problems: Urinary Tract Infection

  MAUDE report 15536902 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN END USER WHO USES INTERMITTENT CATHETERS DEVELOPED A UTI WHILE USING THE HOLLISTER ONLI INTERMITTENT URINARY CATHETER. HE REPORTED THAT HIS LAST UTI WAS 2 YEARS AGO. HE EXPLAINED THAT IN AUGUST, AFTER USING THE ONLI CATHETERS FOR 1 TO 2 WEEKS AND CATHETERIZING UP TO 10 X DAY, HE SAID STARTED EXPERIENCING SYMPTOMS OF A UTI. HE STATED THE SYMPTOMS HE EXPERIENCED WERE CHANGES IN THE SMELL AND COLOR OF HIS URINE. HE REPORTED THAT HE DOES NOT HAVE ANY URINARY TRACT PAIN SENSATION, HOWEVER, HE DOES HAVE THE ABILITY TO EXPERIENCE URINARY FREQUENCY, WHICH HE EXPERIENCED. HE SAID HE WENT TO HIS DOCTOR ON AUGUST 20 AND HAD A UA DONE. THE DOCTOR REPORTEDLY SAID HE HAD A UTI AND PRESCRIBED HIM ORAL ANTIBIOTICS (HE DOES NOT KNOW THE NAME). HE STATED THAT THE DOCTOR DID NOT INDICATE A CAUSE OF HIS UTI. HE DENIES HAVING ANY DIFFICULTY USING THE CATHETERS OR CATHETERIZING HIMSELF. HE REPORTED THAT HE FEELS FINE NOW.

  Patient problems: Urinary Tract Infection

  MAUDE report 15536862 ↗