MAUDE Adverse Event Report: CONVATEC FLEXI SEAL PROTECT FECAL MANAGEMENT SYSTEM (FMS); TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 421630

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

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Ulcer (2274)

Event Date 11/05/2021

Event Type  Death  

Event Description

Patient with fecal management system (fms) in place.Ten days after fms placed, large amount of bright red blood noted in fecal management system.Inpatient due to upper gi (gastrointestinal) bleed related to alcohol abuse, initially thought bleeding from upper gi.Day 11, colonoscopy finding circular ulceration likely from fecal management system bulb found to be source of bleeding, cauterized and biopsied area.Procedure to stop bleeding initially successful, but overnight unresponsive with bright red blood and clots from rectum.Coded and rosc (return of spontaneous circulation) achieved, but in unstable condition.Massive transfusion initiated and second surgery with epi injection and clips x3 tried and unsuccessful.Then taken for rectal artery embolization.Ultimately patient made comfort measures and expired on day 12.

• Brand Name: FLEXI SEAL PROTECT FECAL MANAGEMENT SYSTEM (FMS)
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• MDR Report Key: 12950847
• MDR Text Key: 281839389
• Report Number: 12950847
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 421630
• Device Catalogue Number: 421630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 16425 DA
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White