MAUDE Adverse Event Report: ANIKA THERAPEUTICS INC MONOVISC; SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION

Model Number 690-016

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Arthritis (1723); Arthralgia (2355); Swelling/ Edema (4577)

Event Date 02/19/2021

Event Type  Injury  

Event Description

It was reported by the sales rep via phone that during a knee injection the patient suffered a huge effusion in the knee after monovisc injection.The patient had to be brought to the or to wash out.The device is not available to be returned for evaluation.

Manufacturer Narrative

The event is not confirmed.The device was not returned to the manufacturing plant for evaluation.The device batch record was reviewed.There was no non-conformances associated with this lot.A trend review was performed and confirmed that the reported event is an anticipated event.Trending analysis of the reported event confirms that the overall risk was acceptable and no corrective action was required.This complaint will be re-assessed upon receipt of new and relevant information.

Event Description

This is a follow up submission.See h10 for plant investigation.

• Brand Name: MONOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 11598948
• MDR Text Key: 243394767
• Report Number: 3007093114-2021-00004
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (y/n): N
• PMA/PMN Number: P090031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 690-016
• Device Lot Number: 0000004667
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention