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

Catalog Number	011506
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Constipation (3274)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 13-jun-2024 palette life sciences received the following report from the [patient] "[patient] received a solesta treatment from her [physician] due to fecal incontinence on (b)(6) 2024.After the procedure, the [patient] began to experience constipation.[patient] was hospitalized on (b)(6) 2024 with a bowel impaction that required intervention to remove manually.The [patient] was in the hospital for about 6 hours before being discharged.The [patient] reported that has still not had a normal bowel movement and reported that they are smaller than normal.".Patient reported taking dulcolax, linzess, miralax for constipation post procedure.Multiple attempts for additional information have been requested from the complainant has been unsuccessful at the time of this report.Patient's condition is unknown.
Additional Manufacturer Narrative
Continuation of d11: der and fecal incontinence.Date of implant unknown at the time of this report.Qn#(b)(4), udi number unavailable as complainant did not report a lot number.
Additional Manufacturer Narrative
Continuation of d11: der and fecal incontinence.Date of implant unknown at the time of this report.(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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
On (b)(6) 2024 palette life sciences received the following report from the [patient] "[patient] received a solesta treatment from her [physician] due to fecal incontinence on (b)(6) 2024.After the procedure, the [patient] began to experience constipation.[patient] was hospitalized on (b)(6) 2024 with a bowel impaction that required intervention to remove manually.The [patient] was in the hospital for about 6 hours before being discharged.The [patient] reported that has still not had a normal bowel movement and reported that they are smaller than normal." patient reported taking dulcolax, linzess, miralax for constipation post procedure.Multiple attempts for additional information have been requested from the complainant has been unsuccessful at the time of this report.Patient's condition is unknown.

• 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: 19589425
• Report Number: 3014909464-2024-00005
• Device Sequence Number: 11639339
• Product Code: LNM
• UDI-Device Identifier: 00850004725016
• UDI-Public: 00850004725016
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/02/2024
• 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: AXONICS IMPLANT WHICH IS TO ASSIST OVERACTIVE BLAD; AXONICS IMPLANT WHICH IS TO ASSIST OVERACTIVE BLAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female