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

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

Patient Problem No Code Available (3191)

Event Date 12/07/2018

Event Type  Injury  

Manufacturer Narrative

In the medwatch letter, the physician stated that the device was being used off label.There was no adverse event or serious injury reported in the notification letter.

Event Description

Doctor has prescribed the medication to be injected into hip.Dates of use (b)(6) 2018; diagnosis or reason for use: m16, 12; is the product compounded? no; is the product over the counter? no.

• Brand Name: MONOVISC
• 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: 8236066
• MDR Text Key: 132825516
• Report Number: 3007093114-2018-00019
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090031
• 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: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other