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 Date 09/14/2018

Event Type  Injury  

Manufacturer Narrative

Event was reported to anika via the med watch system.Letter # mw5080756 was sent to anika the week of the 31st of october 2018.In the med watch letter it is stated that the product was being used off label.There was no mention of a serious event in the report received.A contact email was provided and we will attempt to reach out to gain more information.

Event Description

Md is injecting off label into the shoulder.Dates of use: (b)(6) 2018 - present.Diagnosis or reason for use: (b)(4).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: 8204196
• MDR Text Key: 131707188
• Report Number: 3007093114-2018-00014
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1