MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC ORTHOVISC; SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Multiple attempts have been made to obtain additional information regarding the reported hospitalization of the patient, the patient's condition, and the product that was used to treat her.However, this information could not be obtained prior to the required submission deadline of this report.If this information becomes available, a follow-up report will be submitted.
Event or Problem Description
It was reported via email by the jjpaf group that a patient is currently on orthovic and is in the hospital complaining she cannot walk due to the severe pain in her legs.She has been in the hospital for a few days.No further information was provided.

• Brand Name: ORTHOVISC
• Common Device Name: SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 7392090
• Report Number: 3007093114-2018-00005
• Device Sequence Number: 16430102
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2018

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
• Operator of Device: Physician
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 45 YR