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

Catalog Number	011506
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Nausea (1970); Urinary Frequency / Polyuria (2275); Constipation (3274)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review could not be conducted since the lot number of the device was not provided.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Palette life will continue to monitor and trend for reports of this nature.Udi number unavailable as complainant did not report a lot number.
Event or Problem Description
On 14-mar-2024, palette life received notification of the following complaint: "on (b)(6).2024, [palette sales representative] received a phone call on her mobile phone from the patient.This patient was injected with solesta on (b)(6) 2023, by the physician.The patient complains that since the injection he has had a feeling of bowel fullness and constipation, nausea, and no appetite, he has had a ct scan that showed a mass in his rectum.He also complained of urinary urgency and frequency.An mri is scheduled for next week.The patient was advised to follow up with his physician.[palette sales representative] also reached out to [physician] via email to let him know that this patient had called with a complaint and to supply information on [patient history, current status histology, and radiographic imaging]." on 15-mar-2024 additional information was received from [palette sales representative] that stated the following: it was clarified to the [physician] that the patient reported the incident directly to the manufacturer.In addition, the patient previously reported an adverse event with his solesta injection on (b)(6) 2023 that was filed [internally within palette life complaint handling system].On (b)(6) 2024, [palette sales representative] received a phone call from solesta patient with an update on his reported adverse event.[patient] had previously sent an email with his mri results that showed what was assumed to be a solesta bleb pushing against [patient] prostate.The medical plan was to biopsy the mass by a colorectal surgeon within the same medical clinic group.[patient] reported that the biopsy did not take place because the colorectal surgeon could not palpate or identify a mass and therefore could not biopsy the tissue.[patient] plans to seek a second opinion as his urinary frequency and bladder issues continue.

• Brand Name: SOLESTA
• Common Device Name: AGENT, BULKING, INJECTABLE
• 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: 19538941
• Report Number: 3014909464-2024-00002
• Device Sequence Number: 8413025
• Product Code: LNM
• UDI-Device Identifier: 00850004725016
• UDI-Public: 00850004725016
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 011506
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male