MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC Monovisc; Sodium Hyaluronate for Intra Articulate Injection

Model Number	UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	06/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A distributor reported the following to anika via anika customer service: a patient reaction to monovisc injections occurred in the orthopedic office recently.Patient had a significant knee synovitis: white count of 62,500 with 90% neutrophils, cultures negative.".

• Brand Name: Monovisc
• Common Device Name: Sodium Hyaluronate for Intra Articulate Injection
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC; 32 wiggens avenue; bedford MA 01730
• Manufacturer Contact: heather iwaniuk ; 32 wiggens avenue; bedford, MA 01730
• MDR Report Key: 25890036
• Report Number: 3007093114-2026-00014
• Device Sequence Number: 9819458
• Product Code: MOZ
• UDI-Device Identifier: 00817337000104
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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: UNKNOWN
• Device Catalogue Number: 690016
• Device Lot Number: 0000014199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 115 LB