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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 04/05/2018

Event Type  Injury  

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 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
• Type of Device: SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC; 32 wiggins ave; bedford MA 01730
• Manufacturer (Section G): ANIKA THERAPEUTICS, INC; 32 wiggins ave; bedford MA 01730
• Manufacturer Contact: rebecca obeng ; 32 wiggins ave; bedford, MA 01730 ; 7814579500
• MDR Report Key: 8204436
• MDR Text Key: 131766792
• Report Number: 3007093114-2018-00016
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization