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Self-Cath 50220 / 460Recalls & reported problems

Coloplast A/S · No description. · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708932576345), received between Jan 19, 2016 and Jan 19, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Device Output” (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

  • No Device Output1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJan 19, 2016No Device Output

    ACCORDING TO THE INFORMATION RECEIVED, 460 NOT DRAINING. CAN'T TELL IF ITS THE EYELETS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5377788 ↗

Other CATHETER, STRAIGHT devices

All CATHETER, STRAIGHT devices →

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