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

Model Number	690-016
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/29/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Report was received on 24 january 2020, it was determined at the time not to be a reportable event.On 29 january 2020, new information was provided leading to the need to report this case.Mdr was filed on today 03 february 2020.
Event or Problem Description
Reporter called on 24 january2020 to customer service, the customer service report state that the reporter experience reaction, fever and redness after a monovisc treatment.Update information leading to mdr filing received on 29 january 2020 followup call was made to the reporter for additional information on 29jan2020, the reporter mentioned that the complaints was on behalf of his brother who died two days after monovisc treatment.Additional information has been requested from the reporter.

• Brand Name: MONOVISC
• Common Device Name: SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC.; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 9660241
• Report Number: 3007093114-2020-00003
• Device Sequence Number: 11598495
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: FDA PREMARKE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

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: 690-016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/03/2020
• 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: Death