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

Model Number	N/A
Medical Device Problem Code	Missing Value Reason (3192)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	03/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report was received on 27 of march 2018, it was determined at that time not to be a reportable event.On 06 of june 2018, new information was provided leading to the need to report this case.Mdr was filed today, 27 of june 2018.
Event or Problem Description
Case received on 27march2018: patient received a single orthovisc injection on (b)(6) 2018 (tolerated without difficulty).On (b)(6) 2018 patient presented knee pain and was treated with morphine injection and rx for motrin.On (b)(6) 2018 patient complained of swelling and pain, treated with 40 mg of kenalog w/ lidocaine to reduce swelling.On (b)(6) 2018, patient states that pain has continued and has been ordered for an mri.Awaiting mri results as of (b)(6) 2018.Update information leading to mdr filing received on 06june2018: reaction occured within 48 hours of injection.Patient was treated with an incision and drainage of the afflicted knee.Lot number was also provided on this date.

• 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: 7642604
• Report Number: 3007093114-2018-00007
• Device Sequence Number: 14081541
• 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): 06/27/2018

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 Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N170039A
• 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: 06/06/2018
• Initial Report FDA Received Date: 06/27/2018
• 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: Required Intervention
• Patient Age: 82 YR