MAUDE Adverse Event Report: UROMEDICA, INC. UROMEDICA PROACT BLUNT TROCAR

Model Number	750042
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implantation of the patient's left side proact will be performed at a later date.(b)(4).
Event or Problem Description
Bladder perforation in a proact patient.The patient's bladder was perforated with the blunt-tipped trocar during dilation for the patient's left-side proact.The perforation was treated with temporary catheterization.The patient's right-side proact was implanted without incident.

• Brand Name: UROMEDICA PROACT BLUNT TROCAR
• Common Device Name: TROCAR
• 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: 12869240
• Report Number: 3003477176-2021-00015
• Device Sequence Number: 14890132
• Product Code: EZY
• UDI-Device Identifier: 00180668000137
• UDI-Public: 0100180668000137
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P130018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2021

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: 750042
• 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: 10/26/2021
• Initial Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male