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

Device Problem Lack of Effect (4065)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2022

Event Type  Injury  

Manufacturer Narrative

This case is still under investigation by the manufacturing site.A supplemental report will be submitted upon completion of the plant investigation.

Event Description

On 25aug2022 anika received a medwatch (mw5111355) from the fda.It was reported that a patient of unknown age and demographics reported a lack of effect after being treated with a monovisc in the knee.There was no report of any unusual appearance of the device and packaging and there was no malfunction reported.There was no reported delay in the procedure reported.There was no medical intervention reported.The lot number was not reported.The medwatch report did not have any contact information documented.

Event Description

On 25aug2022 anika received a medwatch (mw5111355) from the fda.It was reported that a patient of unknown age and demographics reported a lack of effect after being treated with a monovisc in the knee.There was no report of any unsueual appearance of the device and packaging and there was no malfunction reported.There was no reported delay in the procedure reported.There was no medical intervention reported.The lot number was not reported.The medwatch report did not have any contact information documented.

Manufacturer Narrative

This case is still under investigation by the manufacturing site.A supplemental report will be submitted upon completion of the plant investigation.Supplemental eport.The original medwatch did not include the part number, lot number or details of any malfunction.There was no contact information provided to assist with the investigation.A batch record could not be performed due to no lot number being provided.The status of the patient is unknow.The reported event will continue to be monitored and trended for future analysis.A supplemental report will be submitted upon receipt of additional and relevant information.

• Brand Name: MONOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION.
• Manufacturer (Section D): ANIKA; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: keith kelly ; 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 15429464
• MDR Text Key: 299978623
• Report Number: 3007093114-2022-00010
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other