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

Model Number 00-1111-001-00

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 04/02/2020

Event Type  Death  

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 Description

On 2020-unk - a female patient received gel-one injection into the knee for osteoarthritis.On (b)(6) 2020 - she passed away.

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 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
• Type of Device: 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
• MDR Text Key: 197301660
• Report Number: 9612392-2020-00009
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 00087541300912
• UDI-Public: (01)00087541300912(17)210105(10)0019X24G(422)392
• Combination Product (y/n): N
• PMA/PMN Number: P080020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death