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U.S. Department of Health and Human Services

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

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ANIKA THERAPEUTICS ORTHOVISC SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Nausea (1970); Rash (2033); No Code Available (3191)
Event Date 07/19/2017
Event Type  Injury  
Manufacturer Narrative
In pma# section of this form, the combination product option was already checked off. I was unable to un-check this option. Please note that orthovisc is not a combination product.
 
Event Description
The customer reported via phone that after the second injection of orthovisc the patient experienced hives on their body, nausea, vomiting and required hospitalization. The patient received the injection in one knee. The customer could not provide the lot number. The device was discarded after use.
 
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Brand NameORTHOVISC
Type of DeviceSODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
Manufacturer (Section D)
ANIKA THERAPEUTICS
32 wiggins ave
bedford MA 01730
Manufacturer (Section G)
ANIKA THERAPEUTICS
32 wiggins ave
bedford MA 01730
Manufacturer Contact
armando botelho
32 wiggins ave
bedford, MA 01730
7814579500
MDR Report Key6774630
MDR Text Key82070773
Report Number3007093114-2017-00015
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
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 08/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2017
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? No
Event Location No Information
Date Manufacturer Received08/03/2017
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/08/2017 Patient Sequence Number: 1
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