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 Codes	Implant Pain (4561); Medical device site infection (4845)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent a unilateral explanation of a proact device in (b)(6) 2026.The patient's right balloon was explanted at the scrotum in a supine position.Local anesthetic was given prior to incision.A centimeter incision was made at the scrotal skin where the device port was located.The incision was wiped with culture swabs for further analysis.The device was aspirated with 4cc of fluid, deflated, and explanted.The device remained intact when removed.The balloon was tested on the back table using a 23g hypo needle and a syringe filled with the aspirated mixture.There was no leakage or known perforation.The patient complained about pain around the scrotal area.No erythema.Infection was discovered at time of incision.

• Brand Name: PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
• Common Device Name: PROACT
• Manufacturer (Section D): UROMEDICA, INC.; 1840 berkshire lane n; plymouth MN 55441
• Manufacturer (Section G): UROMEDICA, INC.; 1840 berkshire lane n; plymouth MN 55441
• Manufacturer Contact: 1840 berkshire lane n; plymouth, MN 55441 ; 7636949880
• MDR Report Key: 25201448
• Report Number: 3003477176-2026-00007
• Device Sequence Number: 15976691
• Product Code: EZY
• UDI-Device Identifier: 00180668000380
• UDI-Public: 00180668000380
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P130018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

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: 800018-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/18/2026
• 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