MAUDE Adverse Event Report: Palette Life Sciences US DEFLUX SYRINGE (1ML); AGENT, BULKING, INJECTABLE

Catalog Number	011504
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4) the sample was returned to the manufacturer for evaluation.The manufacturer reported: this complaint has been handled and closed as code 3b (flange brake) based on description and the provided sample.Returned sample inspection: one sample in return, lot 23150, with approximately 0,1 ml gel inside.The syringe flange is broken off.Code 3b applies.The batch record has been reviewed and no deviations or anomalies were identified that can be linked to the complaint.No quality issues found connected to the raw material (syringe, finger grip) which can explain the complaint.Identified root cause: not determined.No further actions will be performed within this complaint, however, the lot is monitored and if relevant, further investigation will be performed.Palette life sciences will continue to monitor and trend for reports of this nature.

• Brand Name: US DEFLUX SYRINGE (1ML)
• Common Device Name: AGENT, BULKING, INJECTABLE
• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 50226073
• Report Number: 3014909464-2026-00085
• Device Sequence Number: 21400964
• Product Code: LNM
• UDI-Device Identifier: 00850004725009
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P000029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2026

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 Catalogue Number: 011504
• Device Lot Number: 23150
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2024
• 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