MAUDE Adverse Event Report: ANIKA THERAPEUTICS INC. MONOVISC; SODIUM HYALAURONATE FOR INTRA-ARTICULAR INJECTION

Lot Number	0000002083
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Initial report (b)(6) 2019."it was reported by the sales rep via email that the patient had a reaction to monovisc injection.The patient received an injection in her right knee and then began to have a itchy, scratchy throat around 30-60 minutes after the injection.The patient was still in the building so they took her immediately to the er.She's not had monovisc in the past and did not know of any allergies prior to the injection.She had no usual activity between the injection & the reaction.When rep spoke with the account, the patient was still being seen in the er and they did not have an update.".

• Brand Name: MONOVISC
• Common Device Name: SODIUM HYALAURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC.; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 8964867
• Report Number: 3007093114-2019-00007
• Device Sequence Number: 2520522
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P090031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2019

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 Expiration Date: 01/31/2022
• Device Lot Number: 0000002083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 09/05/2019
• 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; Required Intervention