MAUDE Adverse Event Report: MEDI-TATE LTD. ITIND, WITH SNARE, STERILE; ITIND SYSTEM

Model Number	WA2ITA00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient called in on (b)(6) 2024 with complaint of hematuria and came for a visit on (b)(6) 2024.It was noted patient had hematospermia.Semen culture (sample collected on (b)(6) 2024) resulted in diagnosis of prostatitis ((b)(6) 2024).And patient was administered levaquin for possibility of infection.Details of the patient's current condition, procedural details and outcome of the procedure were requested but not available at the time of the report.

• Brand Name: ITIND, WITH SNARE, STERILE
• Common Device Name: ITIND SYSTEM
• Manufacturer (Section D): MEDI-TATE LTD.; 14 hailan st.; or akiva, hafia 30600 00; IS 3060000
• MDR Report Key: 19343480
• Report Number: 2429304-2024-00260
• Device Sequence Number: 7069618
• Product Code: KOE
• UDI-Device Identifier: 07290015518062
• UDI-Public: 07290015518062
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2024
• Report Date (Section F): 04/23/2024

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: WA2ITA00
• Device Lot Number: U1S02052022-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/23/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown