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 08july2019 the distributor reported to anika that two monovisc syringes broke during an injection.The break occurred on the luer lock of the syringe.There was no negative patient impact as a result of the event.
|