MAUDE Adverse Event Report: FLEXI-SEAL FMS - FMS FECAL MANAGEMENT SYSTEM KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	418000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Injury (2348)
Date of Event	02/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, this event is deemed a serious injury.No product malfunction was reported.Additional details have been requested but not provided to date.Should additional information become available, a follow up report will be submitted.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.(b)(4).
Event or Problem Description
Complaint received from a nurse reporting that on (b)(6) 2017, "an fms was inserted in a patient who had an existing perianal ulcer." the specific details about the perianal ulcer prior to fms use not provided.On (b)(6) 2017, it was identified that the fms placed in a patient was removed and discontinued.It is not known how much fluid was in the balloon.The nurse stated the "fms in place worsened the existing perianal ulcer" which "has now extend into rectal vault." specific details about the rectal ulcer after fms use was not provided.No additional information is available.
Additional Manufacturer Narrative
This supplemental is being submitted to correct the third party manufacturing site which was submitted incorrectly in the initial mdr on march 10, 2017.No additional details have been provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).

• Brand Name: FLEXI-SEAL FMS - FMS FECAL MANAGEMENT SYSTEM KIT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• MDR Report Key: 6395110
• Report Number: 1049092-2017-00015
• Device Sequence Number: 48075
• Product Code: KNT
• UDI-Device Identifier: 00768455117178
• UDI-Public: 768455117178
• Combination Product (Y/N): N
• Initial Reporter State: OH
• PMA/510(K) Number: K112342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 418000
• Device Catalogue Number: 418000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other