MAUDE Adverse Event Report: CONVATEC INC FMS 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 Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

Device 1 of 1.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.Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

A wound ostomy care nurse reported that a ¿(b)(6) year old female end user with fecal management system (fms) in place that developed necrotic area around her anus".The complainant reports that the patient had an underlying history of diabetes mellitus (dm) and hypertension (htn) and was admitted on (b)(6) 2020, for covid-19.The device was placed on (b)(6) 2020, for liquid stool and removed on (b)(6) 2020, when the necrotic area was noted.As reported the device retention balloon was filled with 45 milliliters (ml) of liquid and 45 ml was removed when the device was discontinued.The patient was in prone position in the bed and it is reported the patient was on a repositioning program.It was reported that there was stool noted in the waste catheter of the device that was liquid brown and bloody.The patient was on heparin and argatroban, per follow up information the patient did not have any history of gastrointestinal bleeding and the bleeding was not a result of the fms device.The device was irrigated on (b)(6) 2020, with 30 ml, but did not received any medication rectally.The wound was treated with diligent cleaning, barrier cream, and avoidance of devices.The patient expired, cause of death was not reported to be related to the fms device, but instead reported to be from covid pneumonia.It was not documented that the patient had a rectal exam done prior to placement of the device, but the facility states " it is standard practice for our institution".There was no report of any rectal procedures done prior to insertion of the device.During a phone call with the facility it was mentioned that the nurse contributes the tissue breakdown to the patients declining health "she was deteriorating and developing skin issues everywhere", " i do not feel that the fms had anything to do with her death nor the breakdown, she was actively dying".No photographs depicting the reported complaint issue was submitted by the complainant.

• Brand Name: FMS SIGNAL
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 10566441
• MDR Text Key: 208749444
• Report Number: 1049092-2020-00172
• 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
• Type of Report: Initial
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• 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
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 76