MAUDE Adverse Event Report: C. R. BARD, INC. BARDEX® MALECOT MODEL DRAIN; CATHETER, MALECOT

Model Number 086034

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Ulcer (2274)

Event Date 04/27/2019

Event Type  Injury  

Event Description

Prolonged intensive care unit course.Had a malecot placed for liquid stool to prevent skin breakdown.Bleeding noted from rectal tube.Had urgent sigmoidoscopy for rectal ulcer and visible vessel.

• Brand Name: BARDEX® MALECOT MODEL DRAIN
• Type of Device: CATHETER, MALECOT
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 8662376
• MDR Text Key: 146794793
• Report Number: 8662376
• Device Sequence Number: 1
• Product Code: FEW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/16/2019,05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 086034
• Device Catalogue Number: 086034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 11315 DA
• Patient Weight: 75