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	Erosion (1750); Urinary Retention (2119); Hematuria (2558)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent bi-lateral implantation of proact.Patient had previous bladder neck contracture and radiation therapy.Patient was in retention after a cystoscopy one week prior to the proact procedure.Each device had 1cc fluid.Urethra was closed shut during post-op cystoscopy.One week later, patient was in retention.Devices were fully deflated and still in retention.Then, patient had gross hematuria, suspicious for an eroded device.Patient came back to or for cystoscopy and to address recurring bladder neck contracture.Patient left device was eroded and removed.Patient right device was reinflated to 0.5cc,and then cystoscopy showed erosion, so that was removed too.Patient sent home with a foley.

• 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 Contact: thomas baker ; 1840 berkshire lane n; plymouth, MN 55441 ; 7636949880
• MDR Report Key: 23872015
• Report Number: 3003477176-2025-00022
• Device Sequence Number: 14782193
• Product Code: EZY
• UDI-Device Identifier: 00180668000380
• UDI-Public: 180668000380
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: 12/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male