MAUDE Adverse Event Report: ANIKA THERAPEUTICS INC ORTHOVISC; SODIUM HYALURONATE FOR INTRAARTICULAR INJECTION

Model Number	630-254
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	02/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Began swelling whole left leg (b)(6) 2020, went to doctor (b)(6) 2020 due to increase swelling.Due to complication from injection and necessary aspiration and surgery, i have increase immobility in leg.Patient reported 2 aspiration.I orthovisc surgery with overnight hospital stay.
Event or Problem Description
Follow-up submission, see h10 for plant investigation.
Additional Manufacturer Narrative
The reported event could not be confirmed.Multiple due diligence attempts were made by the manufacturer to the patient's clinic.No response from the clinic was received.An investigation was performed at the manufacturing plant.The lot number was not provided and the device was not returned to the manufacturing plant for investigation.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.

• Brand Name: ORTHOVISC
• Common Device Name: SODIUM HYALURONATE FOR INTRAARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiigins ave; bedford MA 01730
• MDR Report Key: 11394878
• Report Number: 3007093114-2021-00002
• Device Sequence Number: 1166588
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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 Model Number: 630-254
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 05/04/2021
• 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