MAUDE Adverse Event Report: ANIKA ORTHOVISC; SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION.

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/23/2020

Event Type  Death  

Manufacturer Narrative

The reported event is not confirmed.The cause of the patient's death cannot be established.The lot number was not provided.A review of the batch record was not performed.All product manufactured by anika and anika entities are released to applicable procedures and specifications.The reported event will continue to be monitored and trended for future analysis.A supplemental report will be submitted upon receipt of new and relevant information.

Event Description

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.It was reported to anika by the fda on medwatch report (mw5093903) that a patient of unknown age and demographic has expired.The cause of patient death was not reported, however orthovisc was listed on the medwatch report.There was no allegation of a temporal association between the patient's death and use of the device.The lot number was not provided.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION.
• Manufacturer (Section D): ANIKA; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: keith kelly ; 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 17004847
• MDR Text Key: 315957570
• Report Number: 3007093114-2023-00026
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death