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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA THERAPEUTICS INC. MONOVISC SODIUM HYALAURONATE FOR INTRA-ARTICULAR INJECTION

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ANIKA THERAPEUTICS INC. MONOVISC SODIUM HYALAURONATE FOR INTRA-ARTICULAR INJECTION Back to Search Results
Lot Number 0000002083
Device Problem Insufficient Information (3190)
Patient Problem Local Reaction (2035)
Event Date 08/06/2019
Event Type  Injury  
Event Description
Initial report (b)(6) 2019. "it was reported by the sales rep via email that the patient had a reaction to monovisc injection. The patient received an injection in her right knee and then began to have a itchy, scratchy throat around 30-60 minutes after the injection. The patient was still in the building so they took her immediately to the er. She's not had monovisc in the past and did not know of any allergies prior to the injection. She had no usual activity between the injection & the reaction. When rep spoke with the account, the patient was still being seen in the er and they did not have an update. ".
 
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Brand NameMONOVISC
Type of DeviceSODIUM HYALAURONATE FOR INTRA-ARTICULAR INJECTION
Manufacturer (Section D)
ANIKA THERAPEUTICS INC.
32 wiggins ave
bedford MA 01730
Manufacturer Contact
rebecca obeng
32 wiggins ave
bedford, MA 01730
7814579000
MDR Report Key8964867
MDR Text Key156898538
Report Number3007093114-2019-00007
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P090031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2022
Device Lot Number0000002083
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/30/2019
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: 09/05/2019 Patient Sequence Number: 1
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