MAUDE Adverse Event Report: CONVATEC INC FMS PROTECT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 421630

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Per the information for use: precautions and observations.As long as the patient is regularly and closely monitored at all times, patients may be seated for short periods, i.E.: for up to two (2) hours, as part of daily nursing care.During this period of seating, regular monitoring should be made to ensure the tubing is never blocked or kinked and to check for and avoid pressure damage to the anal/peri-anal region.For some patients, the length of the period of seating to avoid pressure damage to the anal/peri-anal region could be much shorter and the clinician should be alert to this possibility.Position the patient in left side-lying position; if unable to tolerate, position the patient so access to the rectum is possible.Position the length of the flexible catheter along the patient's leg avoiding kinks and obstruction.Take note of the position indicator line relative to the patient's anus.Regularly observe changes to the location of the position indicator line as a means to determine movement of the retention balloon in the patient's rectum.This may indicate the need for the balloon or device to be repositioned.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.(b)(4).

Event Description

It was reported that a patient already in the hospital had a fecal management system (fms) device placed on (b)(6) 2019 and on (b)(6) 2019 it was noted that the patient had a "3.5 x 2.5 x 0.2cm" pressure injury to her left labia majora with "100% yellow/brown necrotic tissue,¿ the device was removed.Per the wound ostomy nurse (won) the area is "unstageable" and was treated with silver gel (brand unknown).It was further reported that when she "went to see the patient the tubing was laying between her legs against her left labia where the breakdown was.We had seen her earlier in the week and there was no skin breakdown prior".The patient was noted to be "sitting up in bed and the tubing was between her legs on the left side against her labia".The won stated ¿she felt like the pressure injury occurred because the device was not repositioned adequately".There was no documentation noted per the won in the patient's chart that the tubing had been repositioned.She also states "they don¿t get every many on the step-down units so they obviously don¿t know how to care for and maintain these".The patient's discharge was not delayed and was discharged back to the extended care facility on september 30, 2019.No other treatments or prescriptions reported for the treatment of the wound besides the silver gel.No photographs depicting the reported complaint issue was submitted by the complainant.

• Brand Name: FMS PROTECT
• 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: 9163979
• MDR Text Key: 168607216
• Report Number: 1049092-2019-00232
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K162906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 421630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2019
• 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
• Patient Age: 65