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

Catalog Number	011506
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fecal Incontinence (4571)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).Udi number unavailable as complainant did not report a lot number.
Event or Problem Description
On 05-jul-2024, palette life sciences received a notification from [patient's family member] "the [patient] underwent a solesta procedure on (b)(6) 2024 for the treatment of fecal incontinence.The [patient] received four injections in the rectum, and this was the first time the [patient] had ever received solesta.The [patient] has been experiencing fecal incontinence for approximately one year.[patient's family member] mentioned that when the [patient] gets up in the morning, feces "comes out" and "goes on the floor." the feces was described as "a bit soft," but not watery like diarrhea.Despite the solesta procedure, the [patient's] fecal incontinence continues.The [patient's family member] stated that the event started on (b)(6) 2024, after the solesta procedure, but with greater frequency since the procedure.The fecal incontinence typically occurs when the [patient] gets up in the morning and has occurred four times at the time of this report, once daily since the [patient] received solesta, except on (b)(6) 2024." the [patient's family member] reported that the [patient] is following a high-fiber diet and taking fiber powder post-procedure.The reporter was advised to contact the patient's physician for further consultation.Multiple attempts to obtain additional information from the complainant have been unsuccessful at the time of this report.The patient's current condition is unknown.
Additional Manufacturer Narrative
Qn#(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 sciences 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 05-jul-2024, palette life sciences received a notification from [patient's family member] "the [patient] underwent a solesta procedure on (b)(6) 2024 for the treatment of fecal incontinence.The [patient] received four injections in the rectum, and this was the first time the [patient] had ever received solesta.The [patient] has been experiencing fecal incontinence for approximately one year.[patient's family member] mentioned that when the [patient] gets up in the morning, feces "comes out" and "goes on the floor." the feces was described as "a bit soft," but not watery like diarrhea.Despite the solesta procedure, the [patient's] fecal incontinence continues.The [patient's family member] stated that the event started on (b)(6) 2024, after the solesta procedure, but with greater frequency since the procedure.The fecal incontinence typically occurs when the [patient] gets up in the morning and has occurred four times at the time of this report, once daily since the [patient] received solesta, except on (b)(6) 2024." the [patient's family member] reported that the [patient] is following a high-fiber diet and taking fiber powder post-procedure.The reporter was advised to contact the patient's physician for further consultation.Multiple attempts to obtain additional information from the complainant have been unsuccessful at the time of this report.The patient's current condition is unknown.

• Brand Name: SOLESTA INJECTABLE GEL
• 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: 19726744
• Report Number: 3014909464-2024-00011
• Device Sequence Number: 8033633
• Product Code: LNM
• UDI-Device Identifier: 00850004725016
• UDI-Public: 00850004725016
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 07/12/2024
• 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.; NONE REPORTED.
• Patient Sex: Male