MAUDE Adverse Event Report: UROMEDICA, INC. PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

Model Number	800018-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urethral Stenosis/Stricture (4501)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A urethral stricture occurred subsequent to a (previously reported) proact device erosion and explantation.The urethral stricture developed where the proact device had previously eroded (reported in 3003477176-2025-00019-00507).Specifically, a 15 french stenosis was noted at the vesicourethral anastomosis.It was resolved via dilation of the bladder neck to 20 french, with no residual effects.The patient had the proact device explanted for at least four months since the date of onset.The event was specified as related to the device, but not the procedure.

• Brand Name: PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
• Common Device Name: PROACT
• Manufacturer (Section D): UROMEDICA, INC.; 1840 berkshire lane north; plymouth MN 55441
• Manufacturer (Section G): UROMEDICA, INC.; 1840 berkshire lane n; plymouth MN 55441
• Manufacturer Contact: 1840 berkshire lane n; plymouth, MN 55441
• MDR Report Key: 25592347
• Report Number: 3003477176-2026-00009
• Device Sequence Number: 14877972
• Product Code: EZY
• UDI-Device Identifier: 00180668000380
• UDI-Public: 00180668000380
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P130018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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
• Device Model Number: 800018-14
• Device Lot Number: UM00981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/23/2026
• 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: Male