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 07august2020 it was reported to ankia by the fda on medwatch report (mw5095586) that a patient's daughter reported that after an orthovisc injection, the patient experienced a reaction the patient reported to the physician.The patient took zertec.It was reported that the patient may be allergic to detergent and would try benadryl if the zertec did not work.There was no report of any medical intervention.There was no report of any malfunction of the device.The lot number was not provided.
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