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SpeediCath Standard 28484Recalls & reported problems

Coloplast A/S · Catheter with accessories containing: 1 ready to use coated catheter, 1 pair of gloves, 1 drape, 2 aseptic cleansing wipes, 1 SpeediBag® 700 ml urine bag. · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708932020350), received between Sep 3, 2019 and Sep 3, 2019 — classified as 1 death.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Cyst(s)1

Recent adverse event reports

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

  • DeathSep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE AVAILABLE INFORMATION, THE END USER DEVELOPED A CYST ON HIS PROSTATE FROM CATHETERIZING, WHICH LED TO SEPSIS AND PASSED AWAY ON TUESDAY (B)(6) 2017 (WE ARE INVESTIGATING THIS DATE AS IT CONFLICTS WITH THE DATE INDICATED FOR START OF USE OF THE PRODUCT) AT (B)(6) HOSPITAL IN (B)(6). DEVICE: COLOPLAST LUBRICATED STRAIGHT 14 FR INTERMITTENT CATHETER - CATHETER WAS IN A GREEN FOIL METAL PACKAGE CONTAINING LIQUID. (NO PRODUCT NUMBER HAS BEEN GIVEN SO WE HAVE USED 28484 FOR THIS COMPLAINT).

    Patient problems: Cyst(s)

    MAUDE report 8957230 ↗

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.