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

Model Number 690-016

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injection Site Reaction (4562)

Event Date 12/04/2021

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon conclusion of the manufacturing investigation.

Event Description

On 17may21, anika received an fda report mw5098536 with the following information: during injection of monovisc, intense pressure and severe pain and upon immediate completion of injection, syncopal event and continued severe pain for weeks and still occurring.When returned to doctor with severe pain, received mri with results of medial femoral condyle stress fracture to same right knee.

Manufacturer Narrative

A manufacturing plant investigation was not performed due to the product not being returned and the lot number was not provided.This symptom will continue to be monitored and trended.A supplemental report will be submitted upon receipt of new and relevant information.

Event Description

See h10 for plant investigation.

• Brand Name: MONOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC.; 32 wiggins avenue; bedford MA 01730
• MDR Report Key: 11962895
• MDR Text Key: 257133055
• Report Number: 3007093114-2021-00072
• 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: other
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

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: Health Professional
• Device Model Number: 690-016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/08/2021
• Supplement Dates Manufacturer Received: 07/23/2021
• Supplement Dates FDA Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: MW5098536
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention