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

Model Number	418000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sex: female based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.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.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
It was reported "we recently had a patient where the flexiseal was utilized from 12/24/2023 -1/6/2024.Upon discontinuation of the rectal tube the patient was noted to have infarcted tissue extruding from the rectum and also developed a rectovaginal fistula." the device was inserted (b)(6) 2023 in a female patient with liquid stool.No details about insertion or patient information available.The device was removed (b)(6) 2024 as they wanted to give imodium and remove the device.Upon removal the bedside nurse noted necrotic tissue extruding from the rectum.The nurse reported 45cc of fluid in balloon upon removal.The patient required surgery to remove the necrotic tissue.During surgery the surgeon discovered a rectovaginal fistula however he recommended repair of the fistula at a later time.The surgeon confirmed with the patient after removal that she had no preexisting issues with the rectum.
Additional Manufacturer Narrative
Corrected data: d4: udi# (b)(4).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 SIGNAL
• 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 27409 ; 3365424679
• MDR Report Key: 18621702
• Report Number: 1049092-2024-00010
• Device Sequence Number: 19425394
• Product Code: KNT
• UDI-Device Identifier: 00768455117178
• UDI-Public: 00768455117178
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K112342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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: 418000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 10/25/2024
• 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 Sex: Unknown