|
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.
|
|
Search Alerts/Recalls
|
|
|