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

Lot Number	PLEASE SEE SECTION H10
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	07/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two lot numbers were reported in this case.The sales representative could not clarify which lot was provided to the patient admitted for pain management.Please find the lot information below: lot # 0000000269, date of manufacture 14feb2018, date of expirary 28feb 2021.Lot # s170104aa, date of manufacture 30nov2017, date of expirary 30nov2020.
Event or Problem Description
It was reported via email by the sales rep that, after speaking with one of the doctors, she was informed that there was a patient who experienced extreme pain and swelling following a monovisc injection.The swelling extended to the ankle and weight-bearing activity was not possible.The patient was eventually sent to the emergency room and admitted for pain management.Additional information is currently not available despite multiple requests.

• Brand Name: MONOVISC
• Common Device Name: SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 7810342
• Report Number: 3007093114-2018-00009
• Device Sequence Number: 11026137
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2018

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: No Information
• Device Lot Number: PLEASE SEE SECTION H10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/23/2018
• 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