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

Model Number	800018-14
Medical Device Problem Codes	Material Rupture (1546); Migration (4003)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was using perineal vibration device for erectile dysfunction for 10 minutes.He noted sudden onset urinary leakage.A pelvic x-ray in (b)(6) 2026 showed a right balloon rupture and left balloon migration.Patient underwent bilateral proact balloon explant and replacement in (b)(6) 2026.The cause stated by the reporter is the perineal vibration device.There was stated to be a device and procedure relationship to the event.The issue was resolved with the bilateral explant and revision of the balloons with no residual effects.

• 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: 25069100
• Report Number: 3003477176-2026-00006
• Device Sequence Number: 13351724
• Product Code: EZY
• UDI-Device Identifier: 00180668000380
• UDI-Public: 00180668000380
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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
• Device Lot Number: UM01072
• 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: 04/24/2026
• Initial Report FDA Received Date: 05/04/2026
• 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