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

Model Number 690-016

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Respiratory Distress (2045); No Code Available (3191)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The sales rep reported via email patient had an injection of monovisc and after 2 hours returned to office not feeling well.Office was unable to diagnose a reaction at this time, but later in the evening the patient went to the er and had a confirmed anaphylactic reaction post-injection.

• Brand Name: MONOVISC
• Type of Device: SODIUM HYALOURONATE 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 MA 01730
• Manufacturer Contact: victoria cassell ; 32 wiggins ave; bedford, MA 01730 ; 7814579500
• MDR Report Key: 6912123
• MDR Text Key: 88105329
• Report Number: 3007093114-2017-00021
• 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: Other
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/30/2019
• Device Model Number: 690-016
• Device Lot Number: S160049AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2016
• 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