MAUDE Adverse Event Report: UROMEDICA INC. PROACT; UROLOGICAL IMPLANT: PRODUCT CODE EZY

Model Number	800018-14
Medical Device Problem Codes	Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Inexperienced surgeon (first few patients).Original port placement unknown.
Event or Problem Description
Patient had multiple port erosions in the perineum.Doctor attempted to salvage in the or at least twice by moving the ports and re-closing the incisions.The patient has now been explanted.

• Brand Name: PROACT
• Common Device Name: UROLOGICAL IMPLANT: 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: 22436436
• Report Number: 3003477176-2025-00011
• Device Sequence Number: 11929702
• Product Code: EZY
• UDI-Device Identifier: 00180668000380
• UDI-Public: 180668000380
• 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 Explanted Year: 2025
• 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): 07/08/2025

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: 06/11/2025
• Initial Report FDA Received Date: 07/08/2025
• 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
• Patient Sex: Unknown