MAUDE Adverse Event Report: DeRoyal Industries, Inc. FOLEY CATHETER, 400 SERIES 16 FR; CATHETER, UPPER URINARY TRACT

Model Number	81-080416
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury

• Brand Name: FOLEY CATHETER, 400 SERIES 16 FR
• Common Device Name: CATHETER, UPPER URINARY TRACT
• Manufacturer (Section D): DeRoyal Industries, Inc.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer (Section G): DeRoyal Industries, Inc.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; +1(865)362-2106
• MDR Report Key: 50846103
• Report Number: 2320762-2026-00026
• Device Sequence Number: 9949406
• Product Code: EYC
• UDI-Device Identifier: 50749756045761
• UDI-Public: 50749756045761
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K200757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 81-080416
• Device Lot Number: 63195327
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown