MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC ORTHOVISC; SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Anika was notified of this event through an medwatch letter (mw0580767).Event occured in (b)(6) 2018, was reported to the fda in (b)(6) 2018, anika was notified the week of (b)(6) 2018.Type of intervention was not described in the mw letter and the reporter did not provide a method of contact.A follow up for more information cannot be performed on this case due to the lack of contact information.
Event or Problem Description
On (b)(6) 2018 (b)(6) pa injected orthovisc to my left knee causing burning pain and blinded pain.Visit to e.R.At (b)(6) hospital because of weakness and pain in left knee got worse overtime.Strength: 30mg/2ml, quantity: 1 each week, 2 injection; frequency: 1 x week consecutive week.Reason for use: arthritis in left knee.Did the problem stop after the person reduce the dose or stopped taking or using the product? no; did the problem return if the person started taking or using the product again? didn't restart.

• Brand Name: ORTHOVISC
• Common Device Name: SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 8204436
• Report Number: 3007093114-2018-00016
• Device Sequence Number: 13870792
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P030019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/28/2018

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 12/28/2018
• 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: Hospitalization