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

Model Number	690-016
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Arrhythmia (1721); Headache (1880); Hot Flashes/Flushes (2153); Eye Pain (4467)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Supplemental report to follow.
Event or Problem Description
A distributor reported that on or about (b)(6) 2020, the patient reportedly experienced intense headaches, palpitation, flushing along with eye pain after receiving a monovisc injection.Six weeks after the monovisc injection, the patient reportedly had two emergency room visits for hypertension and headaches.Additional information is being solicited by the manufacturer.A supplemental report will be submitted upon conclusion of the plant investigation.
Event or Problem Description
Customer reported during routine follow up that this event was previously reported on mdr# 202fls000102.
Additional Manufacturer Narrative
Based on our investigation and solicited information provided by the customer, an association with the reported adverse event monovisc cannot be confirmed.The reported device was not returned to the manufacturing plant for evaluation.The lot number was not provided.Evaluation into the device records do not show any previously reported events or trend that would show a temporal association between the device and the reported event.The manufacturer will track and monitor the reported event.A supplemental report will be submitted up receipt of new and relevant.

• Brand Name: MONOVISC
• Common Device Name: SODIUM HYALURONATE FOR INTRA ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 11787296
• Report Number: 3007093114-2021-00010
• Device Sequence Number: 19703300
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LATANOPROST; ZILRETTA
• Outcome Attributed to Adverse Event: Required Intervention