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

Model Number	800018-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Incontinence (1928); Sepsis (2067); Urinary Retention (2119)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient went into retention after the first volume adjustment.0.5cc were removed and the patient was still in retention.Presumably, additional volume was removed to resolve the retention, but uromedica was not explicitly informed of this.The patient was later hospitalized for sepsis, it is unclear if this is related to uromedica's device or procedure.The patient was leaking at the next office visit.It is not currently clear in what order sepsis and the latest office visit occurred.

• 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 ; 7636499880
• MDR Report Key: 21228852
• Report Number: 3003477176-2025-00001
• Device Sequence Number: 15539182
• Product Code: EZY
• UDI-Device Identifier: 00180668000380
• UDI-Public: 0100180668000380
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/13/2025

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: 01/02/2025
• Initial Report FDA Received Date: 01/24/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Male