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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC MONOVISC; SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION
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ANIKA THERAPEUTICS, INC MONOVISC; SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION Back to Search Results
Medical Device Problem Codes Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Rash (2033)
Date of Event 11/30/2018
Type of Reportable Event Serious Injury
Additional 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 or Problem 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.
 
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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 Key8277261
Report Number3007093114-2019-00001
Device Sequence Number16532730
Product Code MOZ
UDI-Device Identifier10886705025183
UDI-Public10886705025183
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
P090031
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 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
Operator of Device Health Professional
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/17/2019
Initial Report FDA Received Date01/25/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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