MAUDE Adverse Event Report: CONVATEC INC FLEXI-SEAL

Model Number 421630

Device Problem Device Handling Problem (3265)

Patient Problem Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

Common device name: tubes, gastrointestinal (and accessories).Procode: knt.Affiliation: (b)(6) medical center.Per additional information provided by the intake nurse, leakage was found to be around the tube, no product defect.Stool was reported as "watery, loose stool".Rectal exam's are not documented.Upon removal of fms device, poor rectal tone was noted at that time.Since no documentation recorded of rectal exam prior to use, it's unclear if the patient is a good candidate for use of the fms device.Per flexi-seal fecal management system (fms) ifu, a digital rectal exam is required prior to insertion.In addition, small amounts of moisture or seepage around the catheter is anticipated.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).

Event Description

It was reported "that a patient using flexiseal protect fms developed a pressure injury to the perineum.It was also stated there "leakage is around the rectal tube" and they "are seeing an increase in hapis around rectal tubes".Staff is not consistent with use of casp mwf as their skin protectant.They do not irrigate daily.Per additional information received, casp was clarified to be "3m cavilon¿ advanced skin protectant ".A total of 14 patients were identified to have pressure injury to the perineum, however no information was provided for 13 of the patients although information has been requested.This emdr is covering patient #12 of 14 patients reported by this reporter.The remaining patients are covered in subsequent emdrs.

• Brand Name: FLEXI-SEAL
• 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: 15886036
• MDR Text Key: 304541813
• Report Number: 1049092-2022-00432
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00768455143016
• UDI-Public: 768455143016
• Combination Product (y/n): N
• PMA/PMN Number: K181206
• 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: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 421630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2022
• 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