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Conveen Security+ 21346Recalls & reported problems

Coloplast A/S · Conveen Security+. Urine collection bag. Bedside drainage bag. Inlet tube: 55 inch (140 cm). Two step outlet. incl. 1 x bag hanger. Volume 68 oz (2000 ml). · Class 1

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 00762123030196), received between Feb 5, 2020 and Feb 5, 2020 — 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

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.

  • InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE AVAILABLE INFORMATION, DURING THE NIGHT THE URINE FLOW STOPPED, WHICH CAUSED THE URINE TO "BACK UP INTO HIS BLADDER" AND HEREAFTER HE GOT AN UTI, FOR WHICH HE WAS HOSPITALIZED FOR 8 DAYS AND RECEIVED ANTIBIOTICS. THE PATIENT IS NOW HOME AND RECOVERING. IT IS UNCLEAR WHETHER THE TUBE OF THE URINE BAG, THE MEC OR BOTH WERE TWISTED AND CAUSED THE BLOCKED URINE FLOW. THE USER DESCRIBES THAT HE IS USING THE URINE BAG AS DESCRIBED IN THE IFU, EXPECT FOR WASHING IT WITH BLEACH AND WATER AND RE-USING IT.

    Patient problems: Urinary Tract Infection

    MAUDE report 9672878 ↗

Other BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE devices

All BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE devices →

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