This complaint is in scope of a complaint remediation project and has been identified as a complaint that required a mdr based on either the source of the complaint or the type of complaint and is being reported.This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On (b)(6)2020 it was reported to anika by the fda on medwatch report (mw5097264) that a patient experienced pain after ~3 injections of orthovisc.The patient reported difficulty walking.The patient reported that relief lasted about three weeks after the third injection.There was no report of any medical intervention.There was no report of a device malfunction.The lot number(s) were not reported.
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