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

Model Number 630-254

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The fda reported the following which was reported to the fda on mw5101384 by a clinic.The doctors office called in a new prescription for orthovisc for ilateral knee for four weeks.The doctor is aware that this is off-label dosing and wants to continue.Additional information was solicited.

Event Description

The fda reported the following which was reported to the fda on mw5101384 by a clinic.The doctors office called in a new prescription for orthovisc for ilateral knee for four weeks.The doctor is aware that this is off-label dosing and wants to continue.Additional information was solicited.See h10 for additional information.

Manufacturer Narrative

A supplemental report will be submitted upon conclusion of the plant investigation.Additional information: the reported event is not confirmed.The lot number was not provided.A review of the manufacturing record could not be performed.Off label use is an anticipated risk with the use of this device.This case will be re-assessed upon receipt of new and relevant information and a supplemental report will be submitted.This case will be monitored for trending.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiggins avenue; bedford MA 01730
• MDR Report Key: 12127295
• MDR Text Key: 262645064
• Report Number: 3007093114-2021-00178
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 630-254
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 05/14/2021
• Supplement Dates FDA Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: MW5101384
• Patient Sequence Number: 1