On june 15, 2023, viol co.,ltd received an official letter from the fda that an incident report had been received.Based on the contents of the official letter and related medwatch report (mw5118363), an investigation was conducted with (b)(4) an importer, and the following were confirmed.In the report (mw5118363), the reporter said that he/she complained on viol's social media, so (b)(4) and viol's social media were investigated.As a result of the investigation, it was confirmed that two inquiries were made on (b)(4) social media with similar content to the related report (mw5118363).In relationi to this, it was confirmed that (b)(4) who is managing the social media, gave some replies to the inquirer.However, there is little information in the report (mw5118363), so it is difficult to confirm whether the inquirer is the reporter of mw5118363.For this reason, it is difficult to request the hospital to provide patient information ro personal information of the inquirer.Therefore, we request fda to provide the reporter's information for further investigation.If fda provides t he reporter's information, additional investigation will be conducted and follow-up report will be made.
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