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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. MONOVISC; SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
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ANIKA THERAPEUTICS, INC. MONOVISC; SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION Back to Search Results
Model Number 690-016
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes Respiratory Distress (2045); No Code Available (3191)
Date of Event 09/22/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
The sales rep reported via email patient had an injection of monovisc and after 2 hours returned to office not feeling well.Office was unable to diagnose a reaction at this time, but later in the evening the patient went to the er and had a confirmed anaphylactic reaction post-injection.
 
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Brand Name
MONOVISC
Common Device Name
SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
Manufacturer (Section D)
ANIKA THERAPEUTICS, INC.
32 wiggins ave
bedford MA 01730
MDR Report Key6912123
Report Number3007093114-2017-00021
Device Sequence Number750844
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 Other
Type of Report Initial
Report Date (Section B) 10/03/2017
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 No Information
Device Expiration Date06/30/2019
Device Model Number690-016
Device Lot NumberS160049AA
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/11/2017
Initial Report FDA Received Date10/03/2017
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 Hospitalization;
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