MAUDE Adverse Event Report: FLEXI-SEAL SIGNAL FMS RX ZEOLITE; 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); Blood Loss (2597)
Date of Event	10/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brand name - fecal management system signal.Based on the available information, this event is deemed a serious injury.This complaint has been evaluated.No lot number is available.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.No lot number was provided therefore, the specific manufacturing site could not be identified.At this time, no further information was provided.Should additional information become available, a follow up report will be submitted.(b)(4).
Event or Problem Description
The nurse reported the patient developed anal-rectal ulcerations with bleeding and clots while using an fms device.The device was inserted on (b)(6) 2017.On an unspecified date, the patient experienced rectal bleeding, at which time anti-coagulant medications (heparin and baby aspirin) were discontinued.The fms device was removed on (b)(6), 2017.A scope was performed by the gastrointestinal physician, and the patient was treated with a clip in the rectum.Labs were drawn, and a computerized tomography (ct) scan was performed.The patient was diagnosed with ¿anal rectal ulcer s/p epi and clip due to rectal tube placement.¿ no information was provided regarding if a rectal exam was performed prior to placement of the device, or how much fluid was instilled in the retention balloon.The patient outcome was reported as stable.No photographs are available.

• Brand Name: FLEXI-SEAL SIGNAL FMS RX ZEOLITE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• MDR Report Key: 6944768
• Report Number: 1049092-2017-00051
• Device Sequence Number: 505749
• Product Code: KNT
• UDI-Device Identifier: 00768455117178
• UDI-Public: 768455117178
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: 10/06/2017
• Initial Report FDA Received Date: 10/12/2017
• 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
• Patient Age: 54 YR
• Patient Weight: 167