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SpeediCath Standard 28514Recalls & reported problems

Coloplast A/S · SpeediCath Standard. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Female. FR 14/4.7 mm. Rx only. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708932020527), received between Nov 16, 2016 and Nov 16, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Tear, Rip or Hole in Device Packaging1

Patient problems

  • Urinary Tract Infection1

Recent adverse event reports

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

  • InjuryNov 16, 2016Tear, Rip or Hole in Device Packaging

    ACCORDING TO THE AVAILABLE INFORMATION, THE DAUGHTER OF END USER CALLED IN AND SAID HER MOM (THE END USER) GOT A UTI AND THEY THOUGHT IT WAS DUE TO THE PACKAGE HAVING HOLES OR PUNCTURES IN IT. PACKAGE WAS SEALED, BUT THEY SAID THERE WERE HOLES IN THE PACKAGE. THE CATHETER WAS USED AT NIGHT SO THEY DID NOT NOTICE THE HOLES.

    Patient problems: Urinary Tract Infection

    MAUDE report 6106479 ↗

Other CATHETER, URETHRAL devices

All CATHETER, URETHRAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.