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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
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.
 
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Brand NameMONOVISC
Type of DeviceSODIUM 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
kerry wenworth
10 mall road
suite 301
burlington 01730
7814579000
MDR Report Key11787296
MDR Text Key251662226
Report Number3007093114-2021-00010
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P090031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
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 Received05/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number690-016
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2021
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 Treatment Data
Date Received: 05/06/2021 Patient Sequence Number: 1
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