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 Codes	Fever (1858); Muscle Weakness/Atrophy (1967); Nausea (1970); Urinary Tract Infection (2120); Chills (2191); Unspecified Mental, Emotional or Behavioural Problem (4430); Drug Resistant Bacterial Infection (4553)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was initially reported, a patient who had the subject device implanted developed a drug resistant urinary tract infection (uti), had to be given intravenous (iv) antibiotics, and was hospitalized.The provider later reported that the device was implanted on (b)(6) 2024, and explanted on (b)(6) 2024.Five days after explant, the patient started experiencing chills, weakness, nausea, and altered mental status.They presented to the hospital and was found to have a multi drug resistant uti with a urine culture positive for morganella morganii.The patient was treated with ertapenem antibiotic therapy for 7 days with resolution of symptoms as of post operative check on (b)(6) 2024.Of note, the patient had a negative pre-implant urine culture and received single-dose iv antibiotics at the time of pre-implantation and explantation.There were no reports of further patient harm.Due to system limitation for the d2 field, the more accurate device product code is being entered here: qka - temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia.

• 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: 19121026
• Report Number: 2429304-2024-00225
• Device Sequence Number: 12674439
• Product Code: KOE
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2024
• Report Date (Section F): 03/18/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/18/2024
• Date Report to Manufacturer: 03/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2024
• 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; Hospitalization
• Patient Sex: Unknown