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

Model Number	422303
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.Additional information has been requested, however to date no new information has been received.A detailed investigation or batch review cannot be conducted as no lot number was provided.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.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: 1049092.Manufacturing site: 8022978.
Event or Problem Description
Medwatch report # (b)(4) was received from the fda.It was reported that a patient was admitted to intensive care unit for metabolic acidosis and subdural hematoma.The cirrhotic patient with a fecal management system (balloon) developed hemorrhagic shock requiring massive transfusion protocol and use of vasopressors for hemodynamic instability.Egd [esophagogastroduodenoscopy] was performed at bedside and per doctor, pt bleeding was related to fecal containment device that cause ulceration and arterial bleeding.The patient subsequently required an additional 4 units prbcs [packed red blood cells] and up titration of levophed for hemodynamic instability post egd for continued brbpr [bright red blood per rectum].No additional information was provided.No photos available.
Additional Manufacturer Narrative
Correction h10: as per the request received from fda on 16 jul 2025, it was identified that the related report number received as per fda medsun medical device report (mdr) number # (b)(4) was not entered in h10 (related report number) field in the initial emdr.Hence, it has been corrected and entered along with this follow emdr report 01.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: 1049092.Manufacturing site: 8022978.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: FLEXI-SEAL PROTECT PLUS
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3367062840
• MDR Report Key: 22439046
• Report Number: 1049092-2025-00204
• Device Sequence Number: 4593012
• Product Code: KNT
• UDI-Device Identifier: 00768455157150
• UDI-Public: 768455157150
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K190114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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: 422303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/25/2025
• 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: 76 YR
• Patient Sex: Male