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

Catalog Number	011506
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On march 24, 2025, palette life sciences received a notification in which it was reported that "the physician performed a procedure on (b)(6) 2025 and stated the tip of the syringe broke in half during the injection procedure.No adverse event or injury was reported.The procedure was completed with a different syringe from a new kit.The syringe is available for retrieval.".
Event or Problem Description
On march 24, 2025, palette life sciences received a notification in which it was reported that "the physician performed a procedure on (b)(6) 2025 and stated the tip of the syringe broke in half during the injection procedure.No adverse event or injury was reported.The procedure was completed with a different syringe from a new kit.The syringe is available for retrieval.".
Additional Manufacturer Narrative
Qn#(b)(4).Complaint evaluation testing was performed from the sample returned.One empty syringe in return.Number of units and lot is in accordance with report.No defects observed on the syringe.Syringe tip is not broken.It was clarified that the event described as "tip of the syringe broke in half" was, in fact, a needle disconnection.There was no shattering of the syringe or physical harm to the user or patient.Therefore, the event in mdr 3014909464-2025-00017 submitted on april 17, 2025, should be retracted.

• Brand Name: SOLESTA 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: 21860141
• Report Number: 3014909464-2025-00017
• Device Sequence Number: 4721572
• Product Code: LNM
• UDI-Device Identifier: 00850004725016
• UDI-Public: (01)00850004725016(11)220927(17)250831(10)20934(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: 011506
• Device Lot Number: 20934
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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