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

Model Number	630-254
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon conclusion of the plant investigation.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiggins avenue; bedford MA 01730
• MDR Report Key: 12127295
• Report Number: 3007093114-2021-00178
• Device Sequence Number: 16514110
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 630-254
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MW5101384
• Patient Sequence Number: 1