This is a definitive report.This case is received by seikagaku corporation on (b)(6) 2020 from the fda as mw5094339 dated (b)(6) 2020.No further information will be expected, since no contact information is available.The reported lot number was 0018j4g, but it was wrong.Based on the reported expiration date of 2019-11-25, we assume it must be of 0018j14g.According to the result of investigation for 0018j14g, 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.Although the injection date of gel-one was not specified, it is reasonably considered to be prior to the expiration date; 2019-11-25.Since the event occurred in 2020, it is highly unlikely that the event was related to the product.
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