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

Model Number	IPN929650
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "when we injected the product into the silicone holder, the syringe holder broke in half (see photo)." in the photo, it was observed that the syringe flange was broken.No patient harm or injury reported.Multiple attempts for additional information have been requested from the complainant have been unsuccessful at the time of this report.
Additional Manufacturer Narrative
(b)(4).The complaint was evaluated and closed as broken flange based on the information provided, including the complaint description and photographic evidence.A visual assessment of the submitted image was conducted to evaluate overall product condition.The image depicts an empty syringe with a detached/broken flange, with components separated.The lot number could not be verified, as it was not visible in the provided image.A review of the batch records for the reported lot did not identify any deviations or findings that would explain the reported condition.Additionally, no quality issues related to the raw material (glass syringe) were identified that could be associated with this event.The most probable root cause could not be determined.No further investigative actions are planned at this time.The associated lot will continue to be monitored, and additional investigation will be initiated if warranted based on future findings.
Event or Problem Description
It was reported that "when we injected the product into the silicone holder, the syringe holder broke in half." in the photo, it was observed that the syringe flange was broken.No patient harm or injury reported.Multiple attempts for additional information have been requested from the complainant have been unsuccessful at the time of this report.

• Brand Name: DEFLUX INJECTABLE GEL
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23431186
• Report Number: 3014909464-2025-00058
• Device Sequence Number: 13225074
• Product Code: LNM
• UDI-Device Identifier: 00850004725009
• UDI-Public: (01)00850004725009(11)231016(17)260930(10)21918(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

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 Model Number: IPN929650
• Device Catalogue Number: 011504
• Device Lot Number: 21918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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