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

Model Number	800018-14
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Bladder perforation on patient's left side.Contrast was seen coming out of the sheath.Trocar was repositioned and balloon was delivered.Device was not seen on cystoscopy and positioning was good.Both devices were delivered and placement was satisfactory.Patient was sent home with a catheter for 5-7 days.Neobladder patient (post-cystectomy and prostatectomy).

• 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: 23097482
• Report Number: 3003477176-2025-00015
• Device Sequence Number: 8766281
• Product Code: EZY
• UDI-Device Identifier: 00180668000380
• UDI-Public: 180668000380
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 09/19/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 09/19/2025
• 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: Other; Required Intervention
• Patient Sex: Male