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

Model Number	800018-14
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	01/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Uromedica device analysis is not yet complete.Uromedica complaint (b)(4).
Event or Problem Description
Bladder erosion (left-side) in a proact patient.The patient was unilaterally explanted.
Additional Manufacturer Narrative
Uromedica device analysis is not yet complete.Uromedica complaint (b)(4).
Event or Problem Description
Bladder erosion (left-side) in a proact patient.The patient was unilaterally explanted.
Additional Manufacturer Narrative
Health effect - health impact codes updated in relation to newly received information.Uromedica complaint # (b)(4).
Additional Manufacturer Narrative
Device analysis was completed and did not identify any product nonconformities that would have contributed to this adverse event or information that contradicts the narrative of bladder erosion.Adverse event codes updated.Uromedica complaint # (b)(4).

• 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: lisa van ryn ; 1840 berkshire lane north; plymouth, MN 55441
• MDR Report Key: 13457879
• Report Number: 3003477176-2022-00003
• Device Sequence Number: 5786189
• Product Code: EZY
• UDI-Device Identifier: 00180668000380
• UDI-Public: 00180668000380
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2022

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 Expiration Date: 09/24/2023
• Device Model Number: 800018-14
• Device Lot Number: UM00744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 01/07/2022; 05/12/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 04/04/2022; 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2020
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White