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

Model Number 418000

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

Patient Problems Necrosis (1971); Tissue Breakdown (2681)

Event Type  Injury  

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 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.

• Brand Name: FLEXI-SEAL SIGNAL
• Type of Device: 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: 18621702
• MDR Text Key: 334312046
• Report Number: 1049092-2024-00010
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K112342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1