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 21may2023 anika received from the fda a medwatch report (mw5086476) which reported that a patient of unknown age and demographics was prescribed monovisc to be injected in the left hip.There was no report of any patient impact or malfunction with the device.Additional information was not provided.
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