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

Model Number 418000

Device Problem Device Handling Problem (3265)

Patient Problems Pressure Sores (2326); Tissue Breakdown (2681)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

Device 1 of 1.Based on the available information, this event is deemed to be a serious injury.The product was not used in accordance to directions for use contraindications 1: the flexi-seal signal fecal management system ¿ this product is not intended for use for more than twenty-nine (29) consecutive days.Precautions and observations: as with use of any rectal device, the following adverse events could occur: peri-anal skin breakdown.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.The lot number was not provided.Therefore, we are unable to determine the specific manufacturing site.Both potential manufacturing site numbers are listed.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

It was reported by the product user that they had "over the last year they have had patients develop unstageable pressure injuries related to the product".The patient is an (b)(6)-year-old ((b)(6)) male with primary diagnosis of pulseless electrical activity (pea) and cardiac arrest.The fecal management system (fms) device was placed on (b)(6) 2019, it was noted that the patient had a previous fms from (b)(6) 2019 (this product information is unavailable).This fms reported device was placed on (b)(6) 2019 and was in place for a total of fourteen (14) days.The device was in place greater than the recommended twenty-nine (29) days per the product information for use (ifu), the product remained in place once wound was identified, and no digital rectal exam was performed prior to insertion of the device.It is unknown how many milliliters (ml's) were instilled into the product retention balloon.Patient was noted to have a wound at the "stage three (3), 2cm x 1.5cm x 0.3cm at the distal rectum".The wound was treated with "cavilon 2 skin sealant and zinc oxide cream".No photographs depicting the reported complaint issue were received.No lot number provided by 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: 10235533
• MDR Text Key: 197926711
• Report Number: 1049092-2020-00154
• 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: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2020
• 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: 87