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

Lot Number	0000002333,0000002267
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Arthralgia (2355); Joint Swelling (2356)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Worsening pain in the right knee.The 1st injection and 2nd increased pain.After 3rd injection had severe pain and increased swelling.Two weeks later, had to get cortisone injection to decrease swelling and pain which had no effect.Had to take pain med every 6 hrs.Which just dulled the pain.Had problems with sleeping, walking.Dr( b)(6) stated more than ½ of pts have more pain with the injection.Had euflexxa injection with no problems.After 3rd injection, solution felt like a hard rock under the kneecap.Still having more pain than i did before the injection.

• Brand Name: ORTHOVISC
• Common Device Name: SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 9592774
• Report Number: 3007093114-2020-00001
• Device Sequence Number: 13546557
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P030019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2020
• 3 Devices were Involved in the Event: 1 2 3

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: 03/31/2021
• Device Lot Number: 0000002333,0000002267
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2019
• Initial Report FDA Received Date: 01/15/2020
• 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