MAUDE Adverse Event Report: CONSURE MEDICAL, INC. QORA AEON STOOL FECAL MANAGEMENT KIT SYSTEM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number MG-12015-003

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

Patient Problems Death (1802); Exsanguination (1841)

Event Date 11/29/2020

Event Type  malfunction  

Event Description

Patient with rectal tube in place developed hematochezia requiring 5 units of packed red blood cells.Patient passed away on comfort care.

Event Description

Patient with rectal tube in place developed hematochezia requiring 5 units of packed red blood cells.Patient passed away on comfort care.

Event Description

Patient with rectal tube in place developed hematochezia requiring 5 units of packed red blood cells.Patient passed away on comfort care.

• Brand Name: QORA AEON STOOL FECAL MANAGEMENT KIT SYSTEM
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONSURE MEDICAL, INC.; 841 rhode island st suite a; san francisco CA 94107
• MDR Report Key: 11172431
• MDR Text Key: 227042454
• Report Number: 11172431
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MG-12015-003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Weight: 73