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 11june2019 the fda reported to anika medwatch (mw5087187) which reported that a patient of an unknown age and demographic had a minimal response to the monovisc injections.There was no negative patient impact reported.There was no report of a malfunction.The lot number was not provided.The status of the patient is unknown.
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