MAUDE Adverse Event Report: CONVATEC INC L3C3950 - FLEXI-SEAL; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	421630
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Shock (2072); Tissue Breakdown (2681)
Date of Event	11/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A medwatch form was received ((b)(4)).It was reported that a male patient with history of severe alcohol abuse disorder, liver cirrhosis, history of mallory wise tears was admitted with severe upper gi bleed requiring blood transfusion and intervention to stop bleeding.The patient was having what was reported as "profuse persistent liquid stools" so fecal management system placed.The device was in place for ten days when "large amount of bright red blood" was noted in the device.Per the report it was initially thought to be from upper gastrointestinal bleed.On day 11, a colonoscopy was performed and the findings were "circular ulceration likely from fecal management system bulb found to be source of bleeding, cauterized and biopsied area".However, overnight the patient became "unresponsive with bright red blood and clots from rectum".Per the reported, the patient "coded and return of spontaneous circulation was achieved, but patient remained unstable".The patient received "massive transfusion and second surgery with epi injection and clips x3-tried and unsuccessful".The patient was then "taken for rectal artery embolization".The patient was made comfort measures and expired on day 12.The patient's official cause of death "circulatory shock".It was reported that the healthcare providers had "difficulty controlling the bleeding thought to be related to patient's underlying condition".It is unknown if a rectal exam was done prior to placement of the device or how much fluid was instilled to the device retention balloon.No photographs depicting the reported complaint issue were received.
Additional Manufacturer Narrative
Device 1 of 1.Affiliation: (b)(6) medical center.Location: (b)(6).No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Based on the available information, this event is deemed to be a reportable serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: (b)(4).Manufacturing site: (b)(4).

• Brand Name: L3C3950 - FLEXI-SEAL
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 13287533
• Report Number: 1049092-2022-00003
• Device Sequence Number: 14589447
• Product Code: KNT
• UDI-Device Identifier: 00768455143016
• UDI-Public: 00768455143016
• Combination Product (Y/N): N
• Initial Reporter State: MD
• PMA/510(K) Number: K162906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/20/2021

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
• Operator of Device: Health Professional
• 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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 45
• Patient Sex: Male
• Patient Weight: 34 KG
• Patient Race: White