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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
Lot Number 0000000836
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Bacterial Infection (1735)
Type of Reportable Event Serious Injury
Event or Problem Description
Initial report: 24september2018: it was reported by a third-party that following an orthovisc injection from the customer's orthovisc syringe, the patient developed an infection at the injection site.The caller stated that they took cultures from the patient.The caller stated that the syringes are kept at room temperature.The caller could not provide any additional information.The device was discarded by the customer.Update 1:(b)(6) 2018 test cultures yielded positive results for staph.Update 2: (b)(6) 2018: patient was brought to the operating room (or) and the knee was flushed.
 
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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 Key7995018
Report Number3007093114-2018-00011
Device Sequence Number18882520
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 Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/23/2018
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
Device Expiration Date05/31/2020
Device Lot Number0000000836
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/24/2018
Initial Report FDA Received Date10/23/2018
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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