MAUDE Adverse Event Report: PALETTE LIFE SCIENCES DEFLUX INJECTABLE GEL; AGENT, BULKING, INJECTABLE FOR GASTR

Catalog Number	011502
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "when pushing the finger grip of the syringe to inject deflux, the flange broke during use.Therefore, it was replaced with a new one to complete the procedure.No injury to the patient or the physician occurred.".
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: one half full syringe has been returned.Number of units and lot are in accordance with the report.The flange of the syringe is broken.The batch record has been reviewed and no deviations or anomalies were identified that can be linked to the complaint.No quality issues have been found related to the raw material (syringe) that could explain the complaint.The root cause could not be determined.No further actions will be taken regarding this complaint at this time.However, the lot will continue to be monitored, and if relevant, further investigation will be initiated.
Event or Problem Description
It was reported that "when pushing the finger grip of the syringe to inject deflux, the flange broke during use.Therefore, it was replaced with a new one to complete the procedure.No injury to the patient or the physician occurred.".

• Brand Name: DEFLUX INJECTABLE GEL
• Common Device Name: AGENT, BULKING, INJECTABLE FOR GASTR
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23080474
• Report Number: 3014909464-2025-00048
• Device Sequence Number: 10064940
• Product Code: LNM
• UDI-Device Identifier: 00850004725009
• UDI-Public: (01)00850004725009(11)231016(17)260930(10)21921(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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 011502
• Device Lot Number: 21921
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• 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; NONE REPORTED
• Patient Sex: Unknown