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

Model Number 690-016

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Arrhythmia (1721); Headache (1880); Hot Flashes/Flushes (2153); Eye Pain (4467)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

Supplemental report to follow.

Event 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 Description

Customer reported during routine follow up that this event was previously reported on mdr# 202fls000102.

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
• Type of Device: SODIUM HYALURONATE FOR INTRA ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 11787296
• MDR Text Key: 251662226
• Report Number: 3007093114-2021-00010
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (y/n): Y
• PMA/PMN Number: P090031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 690-016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LATANOPROST; ZILRETTA
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR