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 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.The flexi-seal signal fecal management system should not be used on individuals who have any rectal or anal injury.The facility will receive a follow up and in servicing in the next couple of weeks.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 a female patient had a fecal management system (fms) device placed due to "frequent diarrheal stools and incontinence associated dermatitis (iad) on buttocks/perineum".The facility concluded that the patient had a "stage three pressure injury present to anus, extending into the perineal aspect, most likely related to(r/t) rectal tube friction/movement and/or constant leakage of stool".The patient was noted to have the device in place initially (b)(6) 2019 to (b)(6) 2019 and the device was removed, a pressure ulcer diagnosed on (b)(6) 2020.The facility then placed another fms device on the patient on (b)(6) 2020 to (b)(6) 2020, while wound was present.No rectal exam noted to be done prior to device placement.It is unknown how many milliliters (ml's) were placed in the device retention balloon.The wound was treated with perirectal care, zinc oxide cream, turning every two hours.No photographs depicting the reported complaint issue were submitted by the complainant.This incident was not reported to the manufacturer at time of occurrence.Product lot information is unavailable.

• 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: 10228414
• MDR Text Key: 201260944
• Report Number: 1049092-2020-00155
• 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

• 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
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/03/2020
• 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: 83