SpeediCath Compact 28692Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708932579032), received between Nov 17, 2023 and Nov 17, 2023 — 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. How this data works · Data updated Oct 13, 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.

• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, A MALE END-USER USED THE SPEEDICATH COMPACT MALE CATHETER. THE END-USER SAID THE CATHETERISATION FELT WEIRD, BUT THAT THE URINE DRAINED NORMALLY. WHEN THE END-USER WITHDREW THE CATHETER THERE WAS BLEEDING AFTERWARDS. THE BLEEDING WAS DESCRIBED TO CONTINUE FOR 24 HOURS, WITH THE EXCEPTION OF THE NIGHT-TIME. AFTER THE 24 HOURS THE END-USER CONTACTED COLOPLAST. THE END-USER WAS ADVISED TO CONTACT A HEALTH CARE PROFESSIONAL (HCP), WHICH HE DID, AND WAS TOLD TO MONITOR THE BLEEDING FOR THE WEEKEND. AFTER 4 HOURS, THE END-USER FELT BAD, AND AFTER AN ADDITIONAL HOUR HE DEVELOPED A FEVER (38.5°C) AND FELT SICK. HE CONTACTED THE HCP AGAIN AND WAS TOLD TO GO THE EMERGENCY ROOM. THE END-USER WENT TO THE EMERGENCY ROOM BY AMBULANCE AND SPENT THE WEEKEND THERE. SEVERAL TESTS WERE PERFORMED, IN WHICH ONE SHOWED ESCHERICHIA COLI (E. COLI) IN THE URINE, FOR WHICH THE END-USER WAS PRESCRIBED TREATMENT WITH ANTIBIOTICS FOR 10 DAYS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Fever; Hematuria

  MAUDE report 18160121 ↗