MAUDE Adverse Event Report: ANIKA THERAPEUTICS INC ORTHOVISC; SODIUM HYALURONATE FOR INTRA ARTICULAR INJECTION

Model Number 630-254

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2020

Event Type  Death  

Event Description

It was reported by medicare ivr via email that the patient passed away.It was confirmed that the patient has been on orthovisc medication since 2013.No additional information provided.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wigins ave; bedford 01730
• Manufacturer Contact: rebecca obeng ; 32 wiggins ave; bedford, MA 01730 ; 7814579000
• MDR Report Key: 10740610
• MDR Text Key: 213205078
• Report Number: 3007093114-2020-00007
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 630-254
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death