MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE; ACID, HYALURONIC, INTRAARTICULAR

Model Number	00-1111-001-00
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	04/02/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
This case is received by seikagaku corporation on june 8, 2020 from the fda as mw5094703 dated june 1, 2020.According to the result of investigation for 0019x24g, there were no deviations or out-of-specifications, that could relate to the reported adverse event, found in the manufacturing process, the in-process testing, the release testing, and the environmental monitoring.We attempt to contact the reporter for the details through our us partner.
Event or Problem Description
On 2020-unk - a female patient received gel-one injection into the knee for osteoarthritis.On (b)(6) 2020 - she passed away.
Additional Manufacturer Narrative
This is a definitive report.H10 was updated.According to our us partner on (b)(6)2020 , no additional information was expected in the result of the contact on(b)(6)2020 to the reporter.This case is received by seikagaku corporation on(b)(6)2020 from the fda as (b)(4) dated(b)(6)2020.According to the result of investigation for 0019x24g, there were no deviations or out-of-specifications, that could relate to the reported adverse event, found in the manufacturing process, the in-process testing, the release testing, and the environmental monitoring.
Event or Problem Description
(b)(6)2020.- a female patient received gel-one injection into the knee for osteoarthritis.(b)(6)2020 - she passed away.

• Brand Name: GEL-ONE
• Common Device Name: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION; marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0 005; JA 100-0005
• MDR Report Key: 10223560
• Report Number: 9612392-2020-00009
• Device Sequence Number: 18966815
• Product Code: MOZ
• UDI-Device Identifier: 00087541300912
• UDI-Public: (01)00087541300912(17)210105(10)0019X24G(422)392
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P080020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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 Expiration Date: 01/05/2021
• Device Model Number: 00-1111-001-00
• Device Catalogue Number: 00-1111-001-00
• Device Lot Number: 0019X24G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death