MAUDE Adverse Event Report: ORTHOVISC

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.

• Brand Name: ORTHOVISC
• Type of Device: ORTHOVISC
• MDR Report Key: 6267465
• MDR Text Key: 65506245
• Report Number: MW5067366
• Device Sequence Number: 1
• Product Code: MOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2017

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 62 YR
• Patient Weight: 113