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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOVISC

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ORTHOVISC Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Asthma (1726); Pain (1994); Respiratory Distress (2045); Weakness (2145); Arthralgia (2355); Reaction (2414)
Event Type  Injury  
Event Description
I was having a course of 4 orthovisc injections into my right knee. Hae had hyaluronan and supartz on prior occasions without any problems. The reason for using orthovisc was because my new medical insurance would only pay for orthovisc. Five days after the 3rd orthovisc injection, i decided not to have the 4th and final injection because of the following: after each injection, i had knee pain and weakness that lasted for 5-6 days, which was much worse after the 3rd injection. I also had joint pain in other joints. Five days after the 3rd injection, i reached for my office in the car and my deltoid hurt a lot. At this point hours later, it still hurts. My wrists and thumb joints are so painful. It's difficult to grasp and hold a drinking glass. About a week after the 1st inj, i got a chest cold that exacerbated my asthma which is normally a mild condition. This necessitated medrol dosepak and antibiotic treatment. Because i was assured by my dr that all this was coincidence. I continued my orthovisc injections. No more. My breathing has been getting worse, not better. I had to start using a nebulizer with albuterol because my pro air inhaler wasn't helping. Wheezing has gotten progressively worse along with the shortness of breath. I have no fever. There are also no other variables in my medical treatment other than the orthovisc. I haven't been exposed to any new allergies that i know of. Today i have had enough. I will be going back to my internist about the breathing difficulties. This shortness of breath and wheezing is causing me to not able to do any physical, anything. I am short of breath sitting inactive. Never have i had asthma like this. The thought occurred to me that maybe i am allergic to something in the orthovisc injection, so i am reporting to you and stopping treatment. Thanks, (b)(6). How was it taken or used: intra articular. See scanned pages.
 
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Brand NameORTHOVISC
Type of DeviceORTHOVISC
MDR Report Key6267465
MDR Text Key65506245
Report NumberMW5067366
Device Sequence Number1
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/19/2017 Patient Sequence Number: 1
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