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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
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Weakness (2145); Chills (2191); Shaking/Tremors (2515)
Event Type  Injury  
Manufacturer Narrative
At this time no event date or lot number was reported. If the information become available then a follow up report will be made.
 
Event Description
An email was forwarded to mitek cqg concerning an orthovisc patient. From conversation with mr. Marcus pierce this morning, we learned that he has had 2 injections of orthovisc and per his physician's recommendation has stopped the 3rd injection due to, what they believe to be allergy related symptoms. (b)(6) first noticed the symptoms after the 1st injection, he said that the symptoms were like flu, the chills, the weakness, the shakes, but taught nothing of it. The 2nd injection, pretty much the same except that this time it was more severe and that he had uncontrollable shakes and ended up in the er. Tests were done and the results pointed to possible allergies of the orthovisc. (b)(6). , herself a nurse, was a bit upset because she did contact the orthovisc line, spoke to the nurse there and was told that someone was going to call back. It's been a week. She would like to speak to someone who is knowledgeable with the product and would be able to answer her questions.
 
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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
victoria cassell
32 wiggins ave
bedford, MA 01730
7814579000
MDR Report Key6963201
MDR Text Key89797371
Report Number3007093114-2017-00022
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 distributor
Reporter Occupation
Type of Report Initial
Report Date 10/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/26/2017
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: 10/19/2017 Patient Sequence Number: 1
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