MAUDE Adverse Event Report: PALETTE LIFE SCIENCES BARRIGEL INJECTABLE GEL

Model Number	011508
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/15/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
At time of report, no causal link established between patient death and use of barrigel.
Event or Problem Description
3 days following turp of prostate, fiducial marker placement and barrigel insertion, patient passed away at home.Determination of cause of death in-process.
Additional Manufacturer Narrative
At time of follow-up, no causal link established between the patient death and use of barrigel.Physician felt that death was due to pulmonary embolism (unconfirmed) and not related to barrigel or the injection procedure.
Event or Problem Description
Three days following turp of prostate, fiducial marker placement and barrigel insertion, patient passed away at home.Determination of cause of death in-process.
Event or Problem Description
3 days following turp of prostate, fiducial marker placement and barrigel insertion, patient passed away at home.Determination of cause of death in-process.
Additional Manufacturer Narrative
At time of follow-up, no causal link established between the patient death and use of barrigel.Physician felt that death was due to pulmonary embolism (unconfirmed) and not related to barrigel or the injection procedure.

• Brand Name: BARRIGEL INJECTABLE GEL
• Common Device Name: BARRIGEL
• Manufacturer (Section D): PALETTE LIFE SCIENCES; 27 e cota st; suite 402; santa barbara CA 93101
• Manufacturer (Section G): PALETTE LIFE SCIENCES; 27 e cota st; suite 402; santa barbara CA 93101
• Manufacturer Contact: david goodnough ; 27 e cota st; suite 402; santa barbara, CA 93101 ; 8058967087
• MDR Report Key: 17831191
• Report Number: 3014909464-2023-00003
• Device Sequence Number: 19696282
• Product Code: OVB
• UDI-Device Identifier: 00850004725108
• UDI-Public: 00850004725108
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K22641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2023

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 Model Number: 011508
• Device Catalogue Number: 011508
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 09/22/2023; 09/22/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 10/18/2023; 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male