MAUDE Adverse Event Report: CONSURE MEDICAL PRIVATE LIMITED QORA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

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

Patient Problems Fistula (1862); Inflammation (1932); Ulceration (2116)

Event Date 04/28/2020

Event Type  malfunction  

Event Description

Patient had a qora stool management device placed.2 weeks later, the patient underwent a flexible sigmoidoscopy.Findings showed ulceration (greater on the left side) and distal rectal inflammation with fistula formation possibly from rectal tube.Biopsies were taken.

• Brand Name: QORA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONSURE MEDICAL PRIVATE LIMITED; 841 rhode island st. suite a; san francisco CA 94107
• MDR Report Key: 10051408
• MDR Text Key: 190773387
• Report Number: 10051408
• 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: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 05/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21535 DA