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	Urinary Retention (2119); Renal Impairment (4499)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced acute urinary retention following the application of the subject device.It was noted that due to the patient's anatomical presentation, there was difficulty in the application of the subject device, contributing to the retention.The patient presented to the emergency room and was hospitalized for management of urinary retention.The treatment included foley catheter placement, intravenous antibiotics for suspected infection, intravenous hydration, and monitoring of renal function.The urinary retention led to acute kidney injury, which was resolved with management during the stay.During the hospitalization, the subject device was removed.Additionally, as reported, the hospitalization was prolonged due to the patient's pre-existing conditions, including adrenal insufficiency, poorly controlled diabetes, and chronic immunosuppression there were no reports of further patient harm.

• 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: 20909702
• Report Number: 2429304-2024-01033
• Device Sequence Number: 8465951
• Product Code: QKA
• UDI-Device Identifier: 07290015518062
• UDI-Public: 07290015518062
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2024
• Report Date (Section F): 12/11/2024

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: 15032023-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/14/2024
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/11/2024