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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.

Event Description

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 07april2023 anika received a medwatch report (mw5116252) from the fda.It was reported that a patient was asked "since your last refill, have you been hospitalized or had any changes in your medications, allergies, or medical conditions? the patient reported yes, a stroke on an unspecified date in 2023".No additional information was provided.Orthovisc was documented as the product in the medwatch.However, there was no direct allegation made in the medwatch that orthovisc was related to the patient's stroke.The lot number of the device was not provided.Patient contact information was not provided.

Manufacturer Narrative

This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.Supplemental report.The reported event is not confirmed.Additional information could not be obtained since contact information was not provided.There was no report of any defect or appearance issue with the device at the time of use.There was insufficient information for the clinician, who reviewed the case, to determine any cause or make any conclusion.The lot number was not reported.A batch record review could not be 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.(b)(4).

Event Description

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 07april2023 anika received a medwatch report (mw5116252) from the fda.It was reported that a patient was asked "since your last refill, have you been hospitalized or had any changes in your medications, allergies, or medical conditions? the patient reported yes, a stroke on an unspecified date in 2023".No additional information was provided.Orthovisc was documented as the product in the medwatch.However, there was no direct allegation made in the medwatch that orthovisc was related to the patient's stroke.The lot number of the device was not provided.Patient contact information 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: 16852931
• MDR Text Key: 314377197
• Report Number: 3007093114-2023-00014
• 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,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 04/07/2023
• Supplement Dates FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: MW5116252
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization