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
Event or Problem Description
3 days following turp of prostate, fiducial market placement and injection of barrigel patient passed away at home.

• 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 ; 8058697087
• MDR Report Key: 17873497
• Report Number: 3014909464-2023-00004
• Device Sequence Number: 7258411
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2023

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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