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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION

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ANIKA THERAPEUTICS, INC. ORTHOVISC SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION Back to Search Results
Device Problems Off-Label Use (1494); No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems No Information (3190); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This case was reported to the fda with minimal information. Anika received a notification letter (#mw5080459) dated: october 23rd, 2018. The reported information was very vauge and does not indicate, or prove, a serious medical event occured. As stated in the event notification letter, the device was used off label. No adverse event or serious injury was described in the letter. We attempted to reach out to the reporter, (b)(6), but the emails have all bounced back with an error message stating that the email is not valid. This mdr is reported in compliance with fda regulations.
 
Event Description
Prescriber will be using orthovisc in treatment of osteoarthritis in the right shoulder. Right now it is only indicated in osteoarthritis of the knee. Dose or amount: 300mg; frequency: other; route; intra- articular; dates of use: (b)(6) 2018; is the product compounded? no, is the product over the counter? no.
 
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Brand NameORTHOVISC
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 Key8204418
MDR Text Key131700119
Report Number3007093114-2018-00015
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 12/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
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: 12/28/2018 Patient Sequence Number: 1
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