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SpeediCath Compact 28702Recalls & reported problems

Coloplast A/S · SpeediCath Compact Male Kit. Compact with SpeediBag. Urinary catheter for intermittent catheterization. Ready to use coated catheter. Nelaton. Male. Incl. 20 sterile catheters and 20 x non-sterile urine collection bag. 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 05708932624671), received between Feb 5, 2016 and Feb 5, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Partial Blockage” (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

  • Partial Blockage1

Patient problems

  • Discomfort1
  • Pain1

Recent adverse event reports

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

  • InjuryFeb 5, 2016Partial Blockage

    ACCORDING TO THE INFORMATION RECEIVED, END USER HAD BLOCKAGE, NURSE SHOVED CATH THROUGH AND CAUSED A LARGE AMOUNT OF BLOOD TO FLOW. END USER FELT THE NURSE DID SOMETHING WRONG AND CATHETER NOT FAULTY. END USER DID NOT SEEK MEDICAL ATTENTION. END USER REPORTS NO DISCOMFORT/PAIN.

    Patient problems: Discomfort; Pain

    MAUDE report 5412874 ↗

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.