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

Model Number	800018-14
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Abnormal, excessive bleeding on patient from both incision sites.The blood was running out of the sheath excessively when the trocar was removed on both sides.After the devices were placed, the incision sites continued to seep blood at a higher-than-normal rate.The doctor attempted cautery of near the incision site for to stop one of the sources of the bleeding.The doctor applied pressure for 15-20 minutes to stop the bleeding.The bleeding stopped on one incision but continued slowly on the contralateral side.The doctor packed the wound with stericel and closed the incision.The doctor and rep were not able to identify or theorize the source of the bleeding.Cystoscopy was clear, no perforations occurred.The bladder still fully held all contrast and no hematuria was identified.No negative patient effects associated with the bleeding were noted.Nothing abnormal was reported post-operatively.Post-ralp patient.Patient reported stopping low-dose aspirin 7 days before procedure.

• 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: 23091427
• Report Number: 3003477176-2025-00013
• Device Sequence Number: 21281110
• 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): 09/18/2025

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: 09/18/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male