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

Lot Number 0000002083

Device Problem Insufficient Information (3190)

Patient Problem Local Reaction (2035)

Event Date 08/06/2019

Event Type  Injury  

Event 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
• Type of Device: SODIUM HYALAURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC.; 32 wiggins ave; bedford MA 01730
• Manufacturer Contact: rebecca obeng ; 32 wiggins ave; bedford, MA 01730 ; 7814579000
• MDR Report Key: 8964867
• MDR Text Key: 156898538
• Report Number: 3007093114-2019-00007
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Lot Number: 0000002083
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention