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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
Lot Number 0000000818
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 10/24/2018
Event Type  Injury  
Event Description
It was reported by the sales rep via phone that following an monovisc injection, the patient experienced joint effusion. The day after the monovisc injection, the fluid was removed and the patient was given a cortisone injection. The sales rep stated that this was the patient's first injection of monovisc. The sales rep did not know which knee the patient received the injection. The sales rep was not present for the case and could not provide any additional information. The syringe was discarded by the customer.
 
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Brand NameMONOVISC
Type of DeviceSODIUM HYALOURONATE 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 Key8470762
MDR Text Key140530673
Report Number3007093114-2019-00003
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
Type of Report Initial
Report Date 04/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2021
Device Lot Number0000000818
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/01/2019 Patient Sequence Number: 1
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