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 24september2019 anika received from the fda a medwatch report (mw5089680) which reported that a patient required a repeat dose of orthovisc after 4 months.There was no report of any negative patient impact and there is no report of any device malfunction.The status of the patient is unknown.The lot number was not provided.
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