MAUDE Adverse Event Report: UROMEDICA, INC BLUNT-TIP TROCAR

Model Number	750042
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Interoperative bladder perforation (patient's right side) in a proact patient.Perforation treated with temporary catheterization.Right-side implantation was not completed and will be re-attempted in 2-3 months.
Additional Manufacturer Narrative
Patient's left side proact was implanted without incident.Uromedica (b)(4).

• Brand Name: BLUNT-TIP 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: robert mclain ; 1840 berkshire lane north; plymouth, MN 55441 ; 7636949880
• MDR Report Key: 13419227
• Report Number: 3003477176-2022-00004
• Device Sequence Number: 4870911
• Product Code: EZY
• UDI-Device Identifier: 00180668000137
• UDI-Public: 00180668000137
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2022

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: 750042
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 02/01/2022
• 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