MAUDE Adverse Event Report: PALETTE LIFE SCIENCES BARRIGEL INJECTABLE GEL; HYDROGEL SPACER

Catalog Number	011508
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d11: complainant.Qn# (b)(4).Udi number unavailable as complainant did not report a lot number.
Event or Problem Description
On 28-jun-2024 palette life sciences received the following report from a [physcian] in the us "i have a [patient] who is scheduled to be treated with stereotactic body radiotherapy [sbrt] for favorable intermediate risk prostate cancer.Barrigel and fiducials were placed.Magnetic resonance imaging [mri] taken to fuse to computed tomography [ct] simulation images revealed significant infiltration of barrigel into the prostate.The patient is asymptomatic." multiple attempts for additional information have been requested from the complainant has been unsuccessful at the time of this report.
Additional Manufacturer Narrative
Continuation of d11: complainant.(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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
On 28-jun-2024 palette life sciences received the following report from a [physcian] in the us "i have a [patient] who is scheduled to be treated with stereotactic body radiotherapy [sbrt] for favorable intermediate risk prostate cancer.Barrigel and fiducials were placed.Magnetic resonance imaging [mri] taken to fuse to computed tomography [ct] simulation images revealed significant infiltration of barrigel into the prostate.The patient is asymptomatic." multiple attempts for additional information have been requested from the complainant has been unsuccessful at the time of this report.

• Brand Name: BARRIGEL INJECTABLE GEL
• Common Device Name: HYDROGEL SPACER
• Manufacturer (Section D): PALETTE LIFE SCIENCES; santa barbara
• Manufacturer (Section G): PALETTE LIFE SCIENCES; 27 e cota st, suite 402; santa barbara
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19667319
• Report Number: 3014909464-2024-00008
• Device Sequence Number: 6822646
• Product Code: OVB
• UDI-Device Identifier: 00850004725108
• UDI-Public: 00850004725108
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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 Catalogue Number: 011508
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 07/17/2024
• 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: FIDUCIAL MARKERS IMPLANTED, NO DATE PROVIDED FROM; FIDUCIAL MARKERS IMPLANTED, NO DATE PROVIDED FROM
• Patient Age: 61 YR
• Patient Sex: Male