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 or about 09march2020 it was reported to anika by the fda on medwatch report that a patient of unknown age and demographics was hospitalized for an unspecified reason.The lenght of time in the hospital was not reported.The medwatch report (mw5093206) indicates monovisc as the product, however there is no allegation in the report that indicates a temporal association between the use of the device and the patient's hospitalization.There is no report of a malfunction.The lot number of the device was not reported.Contact information was not provided.
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