MAUDE Adverse Event Report: 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	Erosion (1750); Pressure Sore/Ulcer (2326)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.A return sample for evaluation is not expected.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 details have been requested but, not provided to date.The 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.(b)(4).
Event or Problem Description
The nurse reported the hospice patient had the flexi-seal fecal management system (fms) inserted due to diarrhea.The nurse indicated the device was in use for 28 days.The nurse stated the ¿fms tubing rubbed against the mucosa of the rectum resulting in injury.¿ the pressure injury was reported as ¿unstageable¿ and was treated with a packed dressing.At an unspecified time after the reported event, the patient expired.The nurse stated she ¿didn¿t think the cod (cause of death) was related to the flexi issues at all.¿ although requested, no further patient or event details were provided.

• Brand Name: FMS SIGNAL
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• MDR Report Key: 7393746
• Report Number: 1049092-2018-00121
• Device Sequence Number: 1677891
• Product Code: KNT
• UDI-Device Identifier: 00768455117178
• UDI-Public: 768455117178
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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

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: Nurse
• Device Model Number: 418000
• Device Catalogue Number: 418000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 04/03/2018
• 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: Required Intervention