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

Model Number	630-254
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2020
Type of Reportable Event	Death
Event or Problem Description
It was reported by medicare ivr via email that the patient passed away.It was confirmed that the patient has been on orthovisc medication since 2013.No additional information provided.

• Brand Name: ORTHOVISC
• Common Device Name: SODIUM HYALURONATE FOR INTRA ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wigins ave; bedford 01730
• MDR Report Key: 10740610
• Report Number: 3007093114-2020-00007
• Device Sequence Number: 3318420
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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: 630-254
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 10/27/2020
• 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: Death