MAUDE Adverse Event Report: SUPARTZ; INJECTION

Device Problem Insufficient Information (3190)

Patient Problems Cellulitis (1768); Edema (1820); Unspecified Infection (1930); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Date 05/15/2006

Event Type  Injury  

Event Description

In 2006, i had severe knee pain, one of the options was knee replacement surgery.The other was to try supartz injections.My doctor felt we should try the supartz first and i agreed.I was given an injection of supartz on two separate occasions.Immediately after receiving the second injection, i could barely walk out of the doctor's office, i was in severe pain.He told me to go home and put ice on the injection site.I did that and there was very little relief of the pain.A few days later, i was given an ultrasound, which ruled out a blood clot.I was admitted to the hospital and remained there for 10 days.On the 7th or 8th day, i had to have surgery to clean out the area of the infection since it would not heal.I spent several weeks at home with a pic line to continue my healing of the injection.Now, in 2014, i have been diagnosed with lymphedema in the same leg that had the cellulitis.I had to have an ultrasound, ct scan and an mri to verify the condition.I also have had to have two weeks of physical therapy because of the largeness of the leg and to try and aid the lymph nodes to do their job.Now that the therapy is done and the swelling is reduced, i am now required to do the massage myself on my left side and wear compression socks everyday for the rest of my life.Frequency: once a week.

• Brand Name: SUPARTZ
• Type of Device: INJECTION
• MDR Report Key: 3845954
• MDR Text Key: 4409514
• Report Number: MW5036419
• 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: Patient
• Type of Report: Initial
• Report Date: 05/27/2014

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: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/28/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 57 YR
• Patient Weight: 122