MAUDE Adverse Event Report: MEDI-TATE LTD. ITIND, WITH SNARE, STERILE; WA2ITA00

Model Number	WA2ITA00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Micturition Urgency (1871); Implant Pain (4561)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At the post-implant visit, the patient stated pain disrupted his daily activities, affecting his attendance at work due to discomfort.He had to leave work early due to intense pain and pressure and a constant need to urinate.The patient rated the pain ten out of ten.The pain resolved after the device removal visit.There were no further reports of patient impact.

• Brand Name: ITIND, WITH SNARE, STERILE
• Common Device Name: WA2ITA00
• Manufacturer (Section D): MEDI-TATE LTD.; 17 hauman street; hadera 38501 69; IS 3850169
• MDR Report Key: 23437818
• Report Number: 2429304-2025-00285
• Device Sequence Number: 4783220
• Product Code: QKA
• UDI-Device Identifier: 07290015518062
• UDI-Public: 07290015518062
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2025
• Report Date (Section F): 10/31/2025

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: U1S04122023-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/03/2025
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 10/31/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Male
• Date Report Sent to FDA: 10/31/2025