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

Model Number	IPN929649
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the finger wing of a syringe is broken.On the second syringe, the screw ring broke off and the medication squirted out in an uncontrolled manner.No application was possible." multiple attempts for additional information have been requested from the complainant have been unsuccessful at the time of this report.2 devices involved.Associated mdrs:3014909464-2025-00030.
Additional Manufacturer Narrative
(b)(4) complaint verification testing could not be performed as no sample was returned for analysis.There are no deviations or remarks identified in the review of batch records on the reported lot that can explain the complaint.No quality issues were found connected to the raw material which can explain the complaint.The most probable root cause could not be determined.No further actions will be taken regarding this complaint.If the sample becomes available at a later date a follow-up report will be submitted with investigation results.Palette life sciences will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.

• 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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22578668
• Report Number: 3014909464-2025-00031
• Device Sequence Number: 18448932
• Product Code: LNM
• UDI-Device Identifier: 00850004725009
• UDI-Public: (01)00850004725009(11)240216(17)270131(10)22226-1(21)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000029
• 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): 07/03/2025

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 Model Number: IPN929649
• Device Catalogue Number: 011503
• Device Lot Number: 22226-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2024
• 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.
• Patient Sex: Unknown