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

Model Number	418000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Diarrhea (1811); Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device 1 of 1.(b)(6).Based on the available information, this event is deemed to be a serious injury.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.Additional patient / event and product information was requested but, to date no additional information has been receive.Lot number was not provided.Therefore, we are unable to determine the specific third-party manufacturing site.Both potential manufacturing site numbers are listed.Should additional information become available a follow-up report will be submitted.The account was provided product review, bedside tips and ten directions for use posters via email.(b)(4).
Event or Problem Description
It was reported a patient in the hospital "male in his sixties with covid-19 (coronavirus disease 2019) and ventilator dependent, was noted to have a 2cm x 2cm partial to full thickness wound at the distal anal sphincter after approximate two to three weeks of fecal management system (fms) placement".The device was removed and not replaced.It was further reported that after removal of the fms the covid diarrhea continues.They are using triad ointment to the perianal skin and it has nearly healed.Multiple attempts to communicate with the complainant were made but, no response was received from the complainant.The dates the fms was placed, and the date it was removed are not available.No photographs depicting the reported complaint issue were received.No lot number provided.

• Brand Name: FMS SIGNAL
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• MDR Report Key: 10172037
• Report Number: 1049092-2020-00151
• Device Sequence Number: 11202961
• Product Code: KNT
• UDI-Device Identifier: 00768455117178
• UDI-Public: 768455117178
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: K112342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 418000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1