MAUDE Adverse Event Report: CONVATEC, INC. FLEXI-SEAL PROTECT FMS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	421630
Health Effect - Clinical Codes	Diarrhea (1811); Necrosis (1971); Ventricular Fibrillation (2130); Ulcer (2274)
Date of Event	07/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Elderly man was admitted with ventricular fibrillation/ventricular fibrillation arrest related to inferolateral st-elevation myocardial infarction due to catherization for drug eluting stent in right coronary artery.During prolonged hospital course developed large amounts of liquid diarrhea.In order to protect skin, a fecal management system (rectal tube) was employed to control and contain the stool.The tube was placed one week later.During the use of the fecal management system, the balloon was regularly checked, deflated and was inflated with 30-40 ml (below the manufacturer's maximum 45 ml).3 weeks later, the patient developed bright red blood per rectum with hemodynamic decompensation.The patient underwent lower endoscopy which identified an ulcer in the distal rectum consistent with pressure necrosis that had eroded into an artery which was successfully clipped.

• Brand Name: FLEXI-SEAL PROTECT FMS
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONVATEC, INC.; 7900 triad center drive, suite 400; greensboro NC 27409
• MDR Report Key: 10325697
• Report Number: 10325697
• Device Sequence Number: 3574912
• Product Code: KNT
• UDI-Device Identifier: 00768455143016
• UDI-Public: (01)00768455143016(17)24201(10)19FM0515
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2020
• Report Date (Section F): 07/14/2020

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
• Operator of Device: No Information
• Device Model Number: 421630
• Device Catalogue Number: 421630
• Device Lot Number: 19FM0515
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Weight: 100
• Date Report Sent to FDA: 07/14/2020