MAUDE Adverse Event Report: FLEXI-SEAL OTHERS; UNKNOWN

Model Number CCC-UNKNOWN FMS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

A2: sex - male 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.     fda registration number  reporting site: 1049092  manufacturing site: 8022978.

Event Description

It was reported that a consumer/patient experienced skin breakdown of 2 symmetrical straight 1" lines in the shape of the tubing to the perianal area.Mucosa was not affected.It is believed the issue was the result of the customer resting on the fms tubing.The depth of the skin breakdown is described as "stage iii".The fms was in place for several days before the issue was noted and once noted it was discontinued.Eu did not have another fms inserted.No additional information was provided.

• Brand Name: FLEXI-SEAL OTHERS
• Type of Device: UNKNOWN
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 18990469
• MDR Text Key: 338795038
• Report Number: 1049092-2024-00031
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CCC-UNKNOWN FMS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1