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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION.

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ANIKA THERAPEUTICS, INC. ORTHOVISC SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION. Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 05/15/2021
Event Type  Death  
Manufacturer Narrative
This event is still under investigation by the manufacturing plant. A supplemental report will be submitted upon conclusion of the investigation.
 
Event Description
The fda forwarded medwatch mw5103548 to anika where it was reported by the patient's spouse that the patient expired in 2021. Exact date of death is unknown. The patient indication: bilateral post traumatic osteoarthrisis of knee. It is unknown when the patient expired after receiving an orthovisc injection. The cause of the patient's death was not provided. The patient's age and demographics was not provided. Additional information was not provided upon request. Additional information is being solicited.
 
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Brand NameORTHOVISC
Type of DeviceSODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION.
Manufacturer (Section D)
ANIKA THERAPEUTICS, INC.
32 wiggins avenue
bedford MA 01730
MDR Report Key12564430
MDR Text Key274390859
Report Number3007093114-2021-00311
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2021
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? No
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/01/2021 Patient Sequence Number: 1
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