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

Lot Number	S170104BB
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Swelling (2356)
Date of Event	10/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the sales rep via phone that following a monovisc injection, the patient experienced joint effusion in their knee.The sales rep stated that the following day the fluid was removed from the patient and they were given a cortisone injection.The sales rep stated that this was the patient's first injection of monovisc.The sales rep did not know which knee the patient received the injection.The sales rep was not present for the case and could not provide any additional information.The device was discarded by the customer.

• Brand Name: MONOVISC
• Common Device Name: SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 8236067
• Report Number: 3007093114-2018-00020
• Device Sequence Number: 1745222
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P090031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2018

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
• Device Expiration Date: 11/30/2020
• Device Lot Number: S170104BB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 01/10/2019
• 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