MAUDE Adverse Event Report: PALETTE LIFE SCIENCES DEFLUX METAL NEEDLE

Catalog Number	DX1203
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the research subject developed a urinary tract infection after protocol treatment (deflux injection therapy) performed on (b)(6) 2025, and the hospital stay was extended for further treatment.The research subject performed protocol treatment on (b)(6) 2025, and it was completed without any problems, but the following day, march 20, 2025, the subject developed a fever of over 38 c, positive urinary white blood cells, and high inflammatory response.Based on the examination and general condition, fever due to infection and postoperative reaction was suspected.Before injecting deflux transurethrally, saline is injected retrogradely during transurethral surgery to ensure a clear view.However, it was determined that the possibility of increased intravesical pressure, ureteral reflux, and a urinary tract infection due to retrograde infection could not be ruled out.Because a causal relationship to the protocol treatment procedure cannot be ruled out, this event will be reported as a serious illness.The patient's fever quickly subsided with intravenous antibiotics and oral nonsteroidal anti-inflammatory drugs (ndaids), and the inflammatory findings also improved, leading to discharge on (b)(6) 2025.On (b)(6) 2025, the patient returned to the outpatient clinic for the scheduled three-month postoperative visit, and a general urine test revealed no findings suggestive of a urinary tract infection.Therefore, the outcome was recorded as "recovered" on june 20, 2025.".

• Brand Name: DEFLUX METAL NEEDLE
• Common Device Name: METAL NEEDLE
• Manufacturer (Section D): PALETTE LIFE SCIENCES; santa barbara CA
• Manufacturer (Section G): PALETTE LIFE SCIENCES; 27 e cota st, suite 402; santa barbara CA 93101
• Manufacturer Contact: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24381568
• Report Number: 3014909464-2026-00017
• Device Sequence Number: 13384484
• Product Code: LNM
• UDI-Device Identifier: 00850004725023
• UDI-Public: (01)00850004725023(11)231116(17)261031(10)345002(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2026

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 Catalogue Number: DX1203
• Device Lot Number: 345002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.
• Patient Sex: Unknown