SpeediCath Compact 28812Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708932020626), received between Jul 12, 2022 and Jul 12, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INFORMATION AVAILABLE, THE END-USER WAS CONTACTED ON HER 30-DAY FOLLOW UP AND SHE REPORTED THAT, WHILE ON A 3-WEEK TRIP TO (B)(6) WITH HER DAUGHTER SHE HAD BEEN TREATED FOR UROSEPSIS AND SPENT 3 DAYS IN THE HOSPITAL. THE END-USER STARTED EXPERIENCING UTI SYMPTOMS WHICH WAS OCCASIONAL PAIN, BURNING SENSATION AND CLOUDY URINE WHEN SHE URINATED. SHE WENT TO A CLINIC IN (B)(6) BUT WAS INFORMED IT WAS PROBABLY NOTHING. ABOUT 5-6 DAYS AFTER EXPERIENCING THE SYMPTOMS SHE BEGAN TO FEEL INCREDIBLY FATIGUED TO THE POINT OF ALMOST PASSING OUT. SHE WAS TAKEN TO THE EMERGENCY ROOM BY HER DAUGHTER WHERE SHE WAS TREATED FOR UROSEPSIS. THE END-USER WILL NOT USE THE CATHETERS BEFORE SEEING HER DOCTOR. THE END-USER HAD BEEN PROPERLY SANITIZING HER VAGINAL AREA BEFORE AND AFTER CATHETERIZATION. NO MALFUNCTION TO THE CATHETER WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Sepsis

  MAUDE report 14987499 ↗