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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
Medical Device Problem Codes Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes Unspecified Infection (1930); Pain (1994)
Date of Event 07/06/2016
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported via email by mitek's legal counsel that a patient had bi-lateral injections of orthovisc on or about (b)(6) 2016 for osteoarthritis.Within a few days, experienced excruciating pain in the left knee only.He attempted to revisit the facility but was not given a date until (b)(6) 2016.The doctor withdrew fluid and discovered from the lab findings that he had a severe infection.He had emergency irrigation and debridement of his left knee.He underwent a subsequent surgery (b)(6) 2016.
 
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Brand Name
ORTHOVISC
Common Device Name
SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
Manufacturer (Section D)
ANIKA THERAPEUTICS, INC.
32 wiggins ave
bedford MA 01730
MDR Report Key7939810
Report Number3007093114-2018-00010
Device Sequence Number2305652
Product Code MOZ
UDI-Device Identifier10886705023110
UDI-Public10886705023110
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
P030019
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/07/2018
Initial Report FDA Received Date10/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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