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

Model Number	690-016
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Arthritis (1723); Arthralgia (2355); Swelling/ Edema (4577)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem Description
This is a follow up submission.See h10 for plant investigation.

• Brand Name: MONOVISC
• Common Device Name: SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 11598948
• Report Number: 3007093114-2021-00004
• Device Sequence Number: 17045586
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P090031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 690-016
• Device Lot Number: 0000004667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention