MAUDE Adverse Event Report: UROMEDICA INC. PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN; PROACT, PRODUCT CODE: EZY

Model Number	800018-14
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Discomfort (2330); Implant Pain (4561)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient phoned into the clinic with pain on left testicle and feeling some "cords" in the scrotum.
Additional Manufacturer Narrative
Per 08-jan-2025 case report form (crf), patient outcome was "resolved, with no residual effects.".

• Brand Name: PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
• Common Device Name: PROACT, PRODUCT CODE: EZY
• Manufacturer (Section D): UROMEDICA INC.; 1840 berkshire lane north; plymouth MN 55441
• Manufacturer (Section G): UROMEDICA INC.; 1840 berkshire lane north; plymouth MN 55441
• Manufacturer Contact: 1840 berkshire lane north; plymouth, MN 55441 ; 7636949880
• MDR Report Key: 21663365
• Report Number: 3003477176-2025-00004
• Device Sequence Number: 20748817
• Product Code: EZY
• UDI-Device Identifier: 00180668000380
• UDI-Public: 0100180668000380
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P130018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2025

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
• Device Lot Number: UM01025
• 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: 02/27/2025
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown