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

Model Number	800018-14
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Codes	Pocket Erosion (2013); Medical device site infection (4845)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient is planned for a uni-lateral revision (reimplant) to replace the explanted device.
Event or Problem Description
Patient previously underwent bilateral implantation of proact (date unknown, 2025).Patient achieved continence.Then, the port of one proact device eroded through skin of the patient's scrotum.The device was deemed infected.The device was explanted under anesthesia.Cystoscopy was performed and indicated no other injuries to the patient.

• 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: 24532150
• Report Number: 3003477176-2026-00003
• Device Sequence Number: 16039924
• Product Code: EZY
• UDI-Device Identifier: 00180668000380
• UDI-Public: 180668000380
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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: 02/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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