MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC; SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION

Medical Device Problem Codes	Off-Label Use (1494); No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Information (3190); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reported to the fda with minimal information.Anika received a notification letter (#mw5080459) dated: october 23rd, 2018.The reported information was very vauge and does not indicate, or prove, a serious medical event occured.As stated in the event notification letter, the device was used off label.No adverse event or serious injury was described in the letter.We attempted to reach out to the reporter, (b)(6), but the emails have all bounced back with an error message stating that the email is not valid.This mdr is reported in compliance with fda regulations.
Event or Problem Description
Prescriber will be using orthovisc in treatment of osteoarthritis in the right shoulder.Right now it is only indicated in osteoarthritis of the knee.Dose or amount: 300mg; frequency: other; route; intra- articular; dates of use: (b)(6) 2018; is the product compounded? no, is the product over the counter? no.

• 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 Key: 8204418
• Report Number: 3007093114-2018-00015
• Device Sequence Number: 16195911
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P030019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/28/2018

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: No Information
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other