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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Rash (2033)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

We have requested more information from the reporter.Specifically, in regards to lot information, concomitant medication, was this the patient's first injection with the product line, and pre-existing medical conditions or allergies.

Event Description

It was reported by an ethicon nurse via email that following a monovisc injection on (b)(6) 2018, the patient developed dermatitis and an itchy rash.The nurse stated that he developed these symptoms the same day as the injection.The nurse also stated that he has received rounds of prednisone, which lessens his symptoms, but they will return.No additional information was provided.

• Brand Name: MONOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC; 32 wiggins ave; bedford MA 01730
• Manufacturer (Section G): ANIKA THERAPEUTICS, INC; 32 wiggins ave; bedford MA 01730
• Manufacturer Contact: rebecca obeng ; 32 wiggins ave; bedford, MA 01730 ; 7814579500
• MDR Report Key: 8277261
• MDR Text Key: 134080298
• Report Number: 3007093114-2019-00001
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/25/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention