MAUDE Adverse Event Report: DeRoyal Industries, Inc. FOLEY CATHETER, 400 SERIES 8 FR; CATHETER, UPPER URINARY TRACT

Model Number	81-080408
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2026
Type of Reportable Event	Malfunction

• Brand Name: FOLEY CATHETER, 400 SERIES 8 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.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; +1(865)362-2106
• MDR Report Key: 50073941
• Report Number: 2320762-2026-00010
• Device Sequence Number: 10216886
• Product Code: EYC
• UDI-Device Identifier: 00749756045803
• UDI-Public: 00749756045803
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K041416
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 81-080408
• Device Lot Number: 62235534
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 07/29/2026
• 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
• Patient Sex: Unknown