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

Device Problems Off-Label Use (1494); No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems No Information (3190); No Code Available (3191)

Event Type  Injury  

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 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
• Type of Device: SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins ave; bedford MA 01730
• Manufacturer (Section G): ANIKA THERAPEUTICS, INC; 32 wiggins ave; bedford MA 01730
• Manufacturer Contact: rebecca obeng ; 32 wiggins ave; bedford, MA 01730 ; 7814579500
• MDR Report Key: 8204418
• MDR Text Key: 131700119
• Report Number: 3007093114-2018-00015
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• 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): Other