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

Device Problem Off-Label Use (1494)

Patient Problem No Code Available (3191)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

Medwatch letter was received about this case.Physician states in their report to the medwatch system that they were planning on injecting into a shoulder, this is an off label use of the product.Based on the information available, no adverse event was reported at this time.It is our thoughts that the physician wanted to preemptively report the off label use and used the incorrect reporting method.

Event Description

Dr is wanting to inject monovisc into the pt's shoulder.Dates of used: (b)(6) 2018 - present.Diagnosis or reason for use: m19.012, m19.011.Inj 88mg/4ml.

• 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: 8236042
• MDR Text Key: 132787307
• Report Number: 3007093114-2018-00017
• 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: 01/10/2019

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: 11/13/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other