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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA THERAPEUTICS INC ORTHOVISC SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION

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ANIKA THERAPEUTICS INC ORTHOVISC SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION Back to Search Results
Model Number 630-254
Device Problems Off-Label Use (1494); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/14/2021
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon conclusion of the plant investigation.
 
Event Description
The fda reported the following which was reported to the fda on mw5101384 by a clinic. The doctors office called in a new prescription for orthovisc for ilateral knee for four weeks. The doctor is aware that this is off-label dosing and wants to continue. Additional information was solicited.
 
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Brand NameORTHOVISC
Type of DeviceSODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
Manufacturer (Section D)
ANIKA THERAPEUTICS INC
32 wiggins avenue
bedford MA 01730
Manufacturer Contact
32 wiggins avenue
bedford, MA 01730
7813059720
MDR Report Key12127295
MDR Text Key262645064
Report Number3007093114-2021-00178
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 08/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number630-254
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberMW5101384

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