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

Model Number	UNKNOWN
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Edema (1820); Swelling (2091); Patient Problem/Medical Problem (2688)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 15jan 2020, patient report received did not meet the criterial for reporting the incidence.On 29 january 2020, additional information received led to the need for medical device report.This case is reported on 06 february 2020.
Event or Problem Description
On 15 january 2020, (b)(6) from (b)(6) called anika to report that she was experiencing possible allergic reaction to an orthovisc injection and it was provoked in her knee.The same reports was received from this patient through the fda medwatch report mw5092019.On 29 january 2020, patient provided additional information on this case.Patient reported having the orhovisc treatment on (b)(6) 2019 and on (b)(6), experience allergic reaction (hives and rashes over entire body, swelling of feet, knees, and calves, and toes with clear liquid).Patient reported refusing the third injection due to these allergic reactions.Patient reported she had in the past used supartz treatment every six months for several decades because she no longer have meniscus in either knee.Patient reported never experiencing allergic reaction after supartz treatment.

• Brand Name: ORTHOVISC
• Common Device Name: SODIUM HYALURONATE FOR INTRA ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 9678106
• Report Number: 3007093114-2020-00004
• Device Sequence Number: 14173598
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2020

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: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/06/2020
• 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: 84 YR