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Bardex® Malecot Model Drain 086034Recalls & reported problems

C. R. Bard, Inc. · Bardex® Malecot Drain Proportionate Head · 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 00801741023934), received between Jun 27, 2019 and Jun 27, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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

  • Adverse Event Without Identified Device or Use Problem1
  • Use of Device Problem1

Patient problems

  • Hemorrhage/Blood Loss/Bleeding1
  • Ulcer1
  • Ulceration1

Recent adverse event reports

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

  • InjuryJun 27, 2019Use of Device Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT HAD BLEEDING FROM THE TUBE AND A SIGMOIDOSCOPY REVEALED A RECTAL ULCER AND A VISIBLE VESSEL. THE TUBE WAS PLACED FOR FECAL INCONTINENCE MANAGEMENT OF LIQUID STOOLS IN AN IMMUNOCOMPROMISED PATIENT WITH ULCERATIVE COLITIS. THIS DEVICE IS FOR UROLOGICAL PURPOSES ONLY. THE DEVICE WAS IN PLACE FOR 29 DAYS. THE BLEEDING WAS STOPPED VIA CLIPPING OF THE VESSEL.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Ulcer; Ulceration

    MAUDE report 8739158 ↗

Other Catheter, malecot devices

All Catheter, malecot devices →

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