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

Catalog Number 630254

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

Patient Problem Insufficient Information (4580)

Event Type  Death  

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 at 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 21march2024 a medwatch report (mw5152985) was received by anika from the fda.A relative of a patient of unknown age or demographics expired on or about (b)(6) 2024.The cause of death was not reported.Orthovisc (lot not reported) was listed as the product on the medwatch report.However, there was no allegation that the device caused or contributed to the patient's death.The case was forwarded to the distributor and no record of a device malfunction or adverse event was reported that was determined to be related to this case.Patient comorbidities was not reported.Follow up could not be performed due to no contact information on the medwatch report.

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 at the manufacturing plant.Supplemental report: the reported event is not confirmed.It was reported that a patient of unknown age and demographics expired on (b)(6) 2024.Patient comorbidities was not reported.The cause of death was not provided.Due to a lack of contact information on medwatch additional information could not be requested for review.Although orthovisc was referenced on the medwatch, a temporal association could not be established between the patient's death or the use of the device.There was no malfunction or defects with the packaging reported.The lot number was not provided.A batch record review could not be performed.Anika product is manufactured and released to applicable procedures and specifications.A three-year review of all nonconformances was performed for orthovisc.There was no nonconformances documented that was related to the reported event.A three-year retrospective review of retention stock inspections was performed.There was no nonconformances documented in the inspection reports.A review of the most recent stability study report for orthovisc was performed.There were no nonconformances in the report and the conclusion of the report stated that the product has met all required specifications and tolerances.A supplemental report will be submitted upon receipt of new and relevant information.This case will be monitored and trended for future analysis.

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 21march2024 a medwatch report (mw5152985) was received by anika from the fda.A relative of a patient of unknown age or demographics expired on or about (b)(6) 2024.The cause of death was not reported.Orthovisc (lot not reported) was listed as the product on the medwatch report.However, there was no allegation that the device caused or contributed to the patient's death.The case was forwarded to the distributor and no record of a device malfunction or adverse event was reported that was determined to be related to this case.Patient comorbidities was not reported.Follow up could not be performed due to no contact information on the medwatch report.

• 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: 19116475
• MDR Text Key: 340283367
• Report Number: 3007093114-2024-00006
• 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: 04/23/2024

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
• Device Catalogue Number: 630254
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death