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 Problem Tissue Breakdown (2681)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

Device 1 of 1.Based on the available information, this event is deemed to be a reportable malfunction.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 that a nurse "advised a morbidly obese male with multiple co-morbidities including heart issues developed a "full thickness pressure ulcer" of the anus at 600 measuring 3 cm x 1.5 cm.Nurse believes it is a pressure injury related to the fecal management system (fms) tubing.Nurse advised since the patient was morbidly obese and very ill, he was very difficult to turn and position.As a result, the tubing was placed between his legs.The collection bag was very full and heavy".Nurse states" the fms was regularly irrigated, and perianal skin protectant was applied regularly.It is not known if turning of the patient was initiated while fms was in place.It is not known if device was re-positioned on regular intervals.Balloon was inflated with 40 ml of fluid.Fms was inserted for sixteen (16) days, and was discontinued on (b)(6) 2020".The product territory manager provided fms instructional video and information for use literature to the complainant.It is unknown if the patient had a rectal exam prior to placement of the device, it is noted that the patient did not have any prior skin issues to the area prior to device placement.Irrigation was performed regularly due to "policy to irrigate at least once a shift".When the device was removed "40ish ml" was removed from the retention balloon.The patient was bed bound and did not sit on the side of the bed or in a chair.Barrier paste was used to treat the pressure ulcer.No photograph depicting the reported complaint issue was received from 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: 10496057
• MDR Text Key: 206183027
• Report Number: 1049092-2020-00167
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• 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: 08/12/2020
• 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