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

Model Number	800018-02
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Infection in a proact patient, necessitating bilateral explant.
Additional Manufacturer Narrative
Uromedica (b)(4).
Additional Manufacturer Narrative
This follow-up report updates fields and codes relevant to device physical analysis, which was performed after the date of the first version of this report.

• Brand Name: PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
• Common Device Name: PROACT
• 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: robert mclain ; 1840 berkshire lane north; plymouth, MN 55441 ; 7636949880
• MDR Report Key: 15298440
• Report Number: 3003477176-2022-00017
• Device Sequence Number: 20299564
• Product Code: EZY
• UDI-Device Identifier: 00180668000380
• UDI-Public: 00180668000380
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P130018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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: 800018-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (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