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

Model Number 418000

Device Problem Insufficient Information (3190)

Patient Problems Ulcer (2274); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

Device 1 of 1.(b)(4).Fms signal - no lot number reported-cannot confirm vesta/fortune.(additional information was requested but the complainant was only able to provide the product name.Complainant was unable to provide the model number, lot number or product sizing information.) 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.

Event Description

It was reported by the product user facility that they had a patient develop a stage 3 pressure ulcer to the perineum.The patient was reported to be in "very poor health" and expired.The facility states that the patient "did not expire related to the flexiseal" device.The facility had reached out to the product territory manager inquiring if there was a longer tubing option for the device, due to the current type of hospital bed they have.The facility is facing difficulties with placement of the device to keep tubing from becoming too taught.

• Brand Name: L3C3950 - FLEXI-SEAL
• 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 ; 7900 triad center drive; suite 400; greensboro, NC ; 3365424681
• MDR Report Key: 11567369
• MDR Text Key: 242168029
• Report Number: 1049092-2021-00046
• 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 faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 418000
• Device Catalogue 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: 03/10/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1