MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC; 2 ML, 15 MG/ML HIGH MOLECULAR WEIGHT HYALURONAN

Model Number 630-254

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Rash (2033); Swelling (2091)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

Please note that while filling out this form the combination product category was checked off before the page was reached.Nuvisc is not a combination product.Please disregard the checked box as we were unable to unchecked it.

Event Description

The patient reported via phone that after receiving one injection of orthovisc on (b)(6)2017 in each of her knees, she has had a reaction causing her eyes and lips to swell up.She also stated that she has a rash on her neck that is bumpy and has gotten worst.Her knees are fine she stated.The patient followed up with the doctor who advised her to see her general physician.She has been taking benadryl, zyrtec, and prednisone.The patient has an allergy to aspirin and sulfur.No other information was provided.

• Brand Name: ORTHOVISC
• Type of Device: 2 ML, 15 MG/ML HIGH MOLECULAR WEIGHT HYALURONAN
• 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: armando botelho ; 32 wiggins ave; bedford, MA 01730 ; 7814579000
• MDR Report Key: 6817701
• MDR Text Key: 83605803
• Report Number: 3007093114-2017-00018
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P030019
• 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: 08/24/2017

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
• Device Operator: Physician
• Device Model Number: 630-254
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 08/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other