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

Model Number 690-016

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 01/29/2020

Event Type  Death  

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 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
• Type of Device: SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC.; 32 wiggins ave; bedford MA 01730
• Manufacturer (Section G): ANIKA THERAPEUTICS INC; 32 wiggins ave; bedford 01730
• Manufacturer Contact: rebecca obeng ; 32 wiggins ave; bedford, MA 01730 ; 7814579254
• MDR Report Key: 9660241
• MDR Text Key: 177420913
• Report Number: 3007093114-2020-00003
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: FDA PREMARKE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 690-016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death