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

Model Number 630-254

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

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

Event Date 02/04/2020

Event Type  Injury  

Event 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 Description

Follow-up submission, see h10 for plant investigation.

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
• Type of Device: SODIUM HYALURONATE FOR INTRAARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiigins ave; bedford MA 01730
• MDR Report Key: 11394878
• MDR Text Key: 242929863
• Report Number: 3007093114-2021-00002
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (y/n): N
• PMA/PMN Number: P090031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 630-254
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention