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

Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
I was prescribed by my doctors of the (b)(6) orthopedics group your orthovisc to ease my arthritis pain on my knee.Before the injection, i was walking without a cain or any assistance, live in my house enjoying my golden years going swimming with friends with a little pain on my knee.After the injections 3 to each knee, the pain is unbelievably unbearable.I've called my insurance humana; the pharmacist told me maybe 3 times was not enough so the doctor prescribed two more.Finally, i've been injected 3 on the left & 5 on the right knee.2½ months later, i am confined to bed waiting for assistance even to go to the restroom.I cannot walk even with walker.I am not allergic to bird products; i do not have any skin infections or diseases.Your injections mess me up big time.My pcp ordered a mri to determine the catastrophe of my knees.I did it on (b)(6) 2019.Up to now my copay for my insurance the doctor just for the injection is $1000 without copay for doctors mri and assistance.I can't sleep at night from pain.This is a friendly notice from me to you.I need your help in many ways.If you all have an antidote, i have to have it.I need your help to pay all of these bills.If you do not care to answer you gonna hear from my lawyers.

• Brand Name: ORTHOVISC
• Common Device Name: SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 8311988
• Report Number: 3007093114-2019-00002
• Device Sequence Number: 13985000
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2019

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: No Information
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 02/06/2019
• 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: Other; Required Intervention