SpeediCath Standard 28512Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708932020510), received between Jan 26, 2021 and Jan 26, 2021 — 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.

• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE INVOLVES A FEMALE END USER THAT HAD BEEN USING THE SPEEDICATH CATHETER¿S FOR ABOUT 5 DAYS WHEN SHE EXPERIENCED PAIN IN HER SIDE. SHE WENT TO HOSPITAL WHERE SHE WAS DIAGNOSED WITH COVID AND SEPSIS AND WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020. SHE WAS INFORMED BY THE PHYSICIAN IN THE COVID UNIT THAT THE SEPSIS WAS CAUSED BY CATHETERIZATION AND WAS TREATED WITH ANTIBIOTICS. THE END USER CLAIMS SHE HAD SOME CHALLENGES USING THE CATHETERS BUT DISPOSED OF THE CATHETERS CORRECTLY. THE END USER WAS MOVED TO THE REHAB WARD ON (B)(6) 2020. FOLLOWING HER DISCHARGE TESTS WERE PERFORMED AND SHE NOW BELIEVES THE SEPSIS IS HEALED. SHE WAS TOLD SHE MAY NEED TO TAKE ANTIBIOTICS FOR THE REST OF HER LIFE. THE END USER HAS FOLLOW-UP APPOINTMENTS WITH HER PRIMARY CARE PHYSICIAN AND UROLOGIST SCHEDULED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Sepsis

  MAUDE report 11229583 ↗