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 05may2023 the distributor reported to anika that a monovisc syringe broke during the injection.It was unreported where the syringe broke.The patient was splattered with the contents of the syringe but did not experience any negative impact.The patient injection had to be reschedule.The device was discarded by the customer.
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