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

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.

Manufacturer Narrative

This event is still under investigation by the manufacturing plant.A supplemental report will be submitted upon conclusion of the investigation.Additional information was solicited but not provided.The lot number was not provided and additional medical information related to the patient is not available.A temporal association between the use of the device and the patient death cannot be assessed.The reported symptom will be monitored and trended for analysis.A supplemental report will be submitted upon receipt of new and relevant information.

Event Description

The fda forwarded medwatch mw510345 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.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION.
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins avenue; bedford MA 01730
• MDR Report Key: 12564430
• MDR Text Key: 274390859
• Report Number: 3007093114-2021-00311
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death