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

Catalog Number	011503
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On march 26, 2025, palette life sciences received a notification from a [distributor] in switzerland.It was reported that "the thumb rest of the plunger has broken off during use, therefore not all of the gel could be applied.Two syringes involved." additional information received on april 01, 2025 indicated that "there was no injury or adverse event other than having to take new syringes." associated mdr reports: 3014909464-2025-00018.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint evaluation testing was performed from the sample returned.One almost full syringe in return.Number of units and lot is in accordance with report.The syringe has been used and the flange is broken.Visual inspection has been performed of provided picture in terms of overall appearance.Picture displays two used syringes with the flange broken off.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 found connected to the raw material (glass syringe) which can explain the complaint.The most probable root cause could not be 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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
On march 26, 2025, palette life sciences received a notification from a [distributor] in switzerland.It was reported that "the thumb rest of the plunger has broken off during use, therefore not all of the gel could be applied.Two syringes involved." additional information received on april 01, 2025 indicated that "there was no injury or adverse event other than having to take new syringes." associated mdr reports: 3014909464-2025-00018 and 3014909464-2025-00019.

• Brand Name: DEFLUX INJECTABLE GEL
• Common Device Name: AGENT, BULKING, INJECTABLE FOR GASTR
• Manufacturer (Section D): PALETTE LIFE SCIENCES; santa barbara
• Manufacturer (Section G): PALETTE LIFE SCIENCES; 27 e cota st, suite 402; santa barbara
• Manufacturer Contact: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21896253
• Report Number: 3014909464-2025-00019
• Device Sequence Number: 11623596
• Product Code: LNM
• UDI-Device Identifier: 00850004725009
• UDI-Public: (01)00850004725009(11)220906(17)250831(10)20852-1(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P000029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 08/31/2025
• Device Catalogue Number: 011503
• Device Lot Number: 20852-1
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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