MAUDE Adverse Event Report: ANIKA THERAPEUTICS INC MONOVISC; SODIUM HYALURONATE FOR INTRA ARTICULAR INJECTION

Model Number 690-016

Device Problem Device Damaged Prior to Use (2284)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2021

Event Type  malfunction  

Event Description

It was reported by the sales rep via phone that during a knee injection the monovisc injection broke.Another device was used to complete the procedure.No patient consequences or surgical delay reported.The device is available to be returned for evaluation.

Manufacturer Narrative

An investigation was performed at the manufacturing plant.The reported event could not be confirmed.The lot number was not provided and the device was not returned to the manufacturing plant for investigation.Trending analysis of the reported event confirms that the overall risk was acceptable and no corrective action was required.This complaint will be re-assessed upon receipt of new and relevant information.

Event Description

Follow-up submission.See h10 for plant investigation.

• Brand Name: MONOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 11598188
• MDR Text Key: 245969866
• Report Number: 3007093114-2021-00003
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (y/n): N
• PMA/PMN Number: P090031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 690-016
• Device Lot Number: 0000003974
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening