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

Model Number	690-016
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed.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.We will continue to monitor and trend the reported event.
Event or Problem Description
On (b)(6) 2021, fda forwarded the medwatch number mw5100154 to anika inc.It was reported the patient tried and failed medication.Additional information was solicited to the customer, no additional information was provided.

• Brand Name: MONOVISC
• Common Device Name: SODIUM HYALURONATE FOR INTRAARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 11903088
• Report Number: 3007093114-2021-00040
• Device Sequence Number: 3742238
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P090031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2021

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 Model Number: 690-016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/28/2021
• 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: Other